At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Job Summary The Sr. Director, Engineering, Validation and Maintenance is responsible for the ...

60 Alcami Engineers Jobs Hiring Near You
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Job Summary The Sr. Director, Engineering, Validation and Maintenance is responsible for the ...
SAP ABAP Developer
Morrisville, NC · On-site
$57.50 - $78/hr
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... The developer will work closely with functional consultants, business analysts, and cross ...
SAP ABAP Developer
Morrisville, NC · On-site
$57.50 - $78/hr
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... The developer will work closely with functional consultants, business analysts, and cross ...
Sr. Process Engineer
North Charleston, SC · On-site
$80 - $100/hr
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... The Sr. Process Engineer's responsibilities include but are not limited to the following ...
Sr. Process Engineer
North Charleston, SC · On-site
$80 - $100/hr
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... The Sr. Process Engineer's responsibilities include but are not limited to the following ...
Process Engineer
Charleston, SC · On-site
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... The Process Engineer's responsibilities include but are not limited to the following: performing ...
Process Engineer
Charleston, SC · On-site
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... The Process Engineer's responsibilities include but are not limited to the following: performing ...
Sr. Process Engineer
Charleston, SC · On-site
$80 - $100/hr
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... The Sr. Process Engineer's responsibilities include but are not limited to the following ...
Sr. Process Engineer
Charleston, SC · On-site
$80 - $100/hr
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... The Sr. Process Engineer's responsibilities include but are not limited to the following ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Candidates with life sciences or engineering degrees will be considered without manufacturing ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Candidates with life sciences or engineering degrees will be considered without manufacturing ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Excellent ability to read and interpret engineering design, ability to read and understand ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Excellent ability to read and interpret engineering design, ability to read and understand ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Candidates with life sciences or engineering degrees will be considered without manufacturing ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Candidates with life sciences or engineering degrees will be considered without manufacturing ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Excellent ability to read and interpret engineering design, ability to read and understand ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Excellent ability to read and interpret engineering design, ability to read and understand ...
Process Engineer
Charleston, SC · On-site
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... The Process Engineer's responsibilities include but are not limited to the following: performing ...
Process Engineer
Charleston, SC · On-site
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... The Process Engineer's responsibilities include but are not limited to the following: performing ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Candidates with life sciences or engineering degrees will be considered without manufacturing ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Candidates with life sciences or engineering degrees will be considered without manufacturing ...
Process Engineer
Charleston, SC · On-site
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... The Process Engineer is accountable for driving results in a fast-paced environment by providing ...
Process Engineer
Charleston, SC · On-site
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... The Process Engineer is accountable for driving results in a fast-paced environment by providing ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Engineering, etc.) on continuous improvement initiatives to enhance product quality, safety, and ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Engineering, etc.) on continuous improvement initiatives to enhance product quality, safety, and ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Candidates with life sciences or engineering degrees will be considered without manufacturing ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Candidates with life sciences or engineering degrees will be considered without manufacturing ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Candidates with life sciences or engineering degrees will be considered without manufacturing ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Candidates with life sciences or engineering degrees will be considered without manufacturing ...
$80 - $100/hr
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... EHS and Engineering to ensure robust production of cGMP Sterile Drug Products. The position ...
$80 - $100/hr
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... EHS and Engineering to ensure robust production of cGMP Sterile Drug Products. The position ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... EHS and Engineering to ensure robust production of cGMP Sterile Drug Products. The position ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... EHS and Engineering to ensure robust production of cGMP Sterile Drug Products. The position ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... EHS and Engineering to ensure robust production of cGMP Sterile Drug Products. The position ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... EHS and Engineering to ensure robust production of cGMP Sterile Drug Products. The position ...
Sr. Validations Specialist
Morrisville, NC · On-site
$77K - $106K/yr
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Bachelor's Degree in Engineering, Chemistry, Biology, or related field required. * 5+ years of ...
Sr. Validations Specialist
Morrisville, NC · On-site
$77K - $106K/yr
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Bachelor's Degree in Engineering, Chemistry, Biology, or related field required. * 5+ years of ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Engineering, etc.) on continuous improvement initiatives to enhance product quality, safety, and ...
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from ... Engineering, etc.) on continuous improvement initiatives to enhance product quality, safety, and ...
Alcami Jobs Information
Do workers at Alcami get paid breaks?
83% of people say they don’t get paid breaks.
Based on data from 6 people who took the Breakroom Quiz between January 2025 and June 2026.
Does Alcami pay people when they’re sick?
100% of people say they would get paid if they were sick but scheduled to work.
Based on data from 7 people who took the Breakroom Quiz between January 2025 and June 2026.
At Alcami, are sick days and vacation days separate paid time off?
40% of people say they have to use vacation days when they’re out sick.
Based on data from 5 people who took the Breakroom Quiz between June 2025 and June 2026.
Is the health insurance from Alcami affordable enough for their workers?
80% of people say the health insurance costs are okay
Based on data from 5 people who took the Breakroom Quiz between June 2025 and June 2026.
Do people get paid time off at Alcami?
100% of people say they get paid time off.
Based on data from 5 people who took the Breakroom Quiz between June 2025 and June 2026.
Do workers at Alcami worry about hours?
100% of people report they don’t worry about getting enough hours.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and January 2026.
Do Alcami workers get to choose the shifts they work?
80% report that they don’t have enough control over which shifts they work.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and November 2025.
How easy is it to get time off at Alcami?
38% of people report it’s hard to get time off.
Based on data from 8 people who took the Breakroom Quiz between January 2025 and June 2026.
Do Alcami managers change schedules at the last minute?
83% of people say their manager doesn’t change their shift schedule at the last minute.
Based on data from 6 people who took the Breakroom Quiz between January 2025 and January 2026.
Do jobs at Alcami spill into time workers aren’t paid for?
20% of people report that their job takes up time that they don’t get paid for.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and January 2026.
How easy is it to take sick days at Alcami?
38% of people report that it’s hard to take time off if they are sick.
Based on data from 8 people who took the Breakroom Quiz between January 2025 and June 2026.
Do people at Alcami feel treated with respect by their managers?
75% of people say they’re treated with respect by their managers.
Based on data from 8 people who took the Breakroom Quiz between January 2025 and June 2026.
Do people at Alcami get to take their breaks without interruption?
57% of people report that their breaks get interrupted.
Based on data from 7 people who took the Breakroom Quiz between January 2025 and June 2026.
Is it stressful to work at Alcami?
86% of people say they often feel stressed at work.
Based on data from 7 people who took the Breakroom Quiz between January 2025 and June 2026.
Do people at Alcami enjoy their jobs?
71% of people report they enjoy their job.
Based on data from 7 people who took the Breakroom Quiz between January 2025 and June 2026.
Do people at Alcami recommend working with their team?
67% of people report that they wouldn’t recommend working with their immediate team to a friend.
Based on data from 9 people who took the Breakroom Quiz between January 2025 and June 2026.
Do people get enough training when they start at Alcami?
38% of people report they didn’t get enough training when they started working here.
Based on data from 8 people who took the Breakroom Quiz between January 2025 and June 2026.
Do people get support to advance at Alcami?
In the last year, 57% of people report not being given support to advance their career here.
Based on data from 7 people who took the Breakroom Quiz between January 2025 and April 2026.
Do people think Alcami’s headquarters understands what’s happening where they work?
88% of people think that this employer’s headquarters or owners don’t have a good understanding of what’s really happening where they work.
Based on data from 8 people who took the Breakroom Quiz between January 2025 and June 2026.
Do workers feel well informed about how Alcami is doing?
80% of people feel that they are kept well informed about how the company is doing as a whole.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and June 2026.
What are the most popular job types at Alcami?
What are the most popular jobs at Alcami?
What are the most popular categories at Alcami?

Full-time
Posted 29 days ago
Alcami rating
7.8
Based on 9 frontline employees who took The Breakroom Quiz
Job description
Are you interested in joining our team?
Job Summary
The Sr. Director, Engineering, Validation and Maintenance is responsible for the strategic leadership, development, and execution of engineering, validation, maintenance, reliability, and manufacturing automation programs that support current operations and future growth of the site. This role provides end-to-end lifecycle ownership of facility, utility, manufacturing, laboratory, and automation systems, ensuring regulatory compliance, operational excellence, asset reliability, and business continuity.
The Sr. Director leads all aspects of engineering, including capital project planning and execution, facility and utility design, equipment procurement, installation, commissioning, and lifecycle management. The role oversees validation activities, including commissioning, qualification (IQ/OQ/PQ), computerized system validation, and ongoing requalification programs. Additionally, the position is responsible for site maintenance, metrology, and reliability engineering programs focused on maximizing equipment uptime, optimizing asset performance, reducing operational risk, and implementing predictive and reliability-centered maintenance strategies.
The role also provides leadership for manufacturing automation and digital infrastructure, including process control systems, SCADA, PLCs, manufacturing data systems, historian platforms, and computerized systems that support GMP manufacturing operations. The Sr. Director drives automation and digital transformation initiatives that improve process robustness, data integrity, operational efficiency, and manufacturing scalability.
As a key member of the site leadership team, the Sr. Director develops and executes long-range capital and infrastructure strategies while ensuring facility, utility, contamination control, and automation systems remain aligned with current regulatory expectations and business objectives. The position serves as a technical leader during client interactions, regulatory inspections, and corporate initiatives, while building organizational capability through talent development, succession planning, and continuous improvement.
This role fosters a culture of safety, quality, compliance, reliability, innovation, and operational excellence by leveraging modern engineering practices, Lean principles, risk-based decision-making, and cross-functional collaboration to support the successful delivery of sterile pharmaceutical manufacturing operations.
On-Site Expectations
- 100% on-site position.
- 1st Shift: Monday - Friday, 8:00am - 5:00pm.
Responsibilities
Leadership, Strategy, and Organizational Development
- Develop, implement, and continuously improve site engineering, validation, maintenance, metrology, reliability, and automation strategies that support current operations, future growth, compliance, and operational excellence objectives.
- Establish departmental goals, key performance indicators (KPIs), and long-range strategic plans aligned with business objectives and network standards.
- Build, develop, and retain a high-performing technical organization through effective leadership, coaching, mentoring, succession planning, and talent development.
- Foster a culture of safety, quality, accountability, innovation, operational excellence, and continuous improvement.
- Represent the department on site leadership teams, governance forums, client meetings, audits, inspections, and cross-functional initiatives.
- Develop and manage departmental operating budgets and long-range capital investment plans.
Engineering and Technical Operations
- Provide strategic and technical leadership for facility, utility, manufacturing, laboratory, and process support systems throughout the asset lifecycle.
- Oversee engineering activities including conceptual design, scope development, budgeting, procurement, construction management, installation, commissioning, startup, and lifecycle management.
- Ensure equipment, facility, utility, and automation systems are designed, maintained, and operated in accordance with cGMP, regulatory requirements, corporate standards, and industry best practices.
- Serve as the site subject matter expert (SME) for facility infrastructure, clean utilities, process equipment, contamination control systems, and critical GMP support systems.
- Support sterile manufacturing operations through effective management of engineering resources and technical problem-solving.
Validation and Compliance
- Oversee facility, utility, equipment, process, and computerized system validation programs.
- Ensure execution of commissioning, qualification, and validation activities including FAT, SAT, IQ, OQ, PQ, requalification, and periodic review programs.
- Partner with Quality to maintain compliant validation systems aligned with cGMP, FDA, EMA, ICH, ISPE, and corporate requirements.
- Support internal audits, customer audits, and regulatory inspections while ensuring timely completion of commitments and corrective actions.
- Drive continuous improvement of validation lifecycle management and risk-based qualification practices.
Reliability Engineering and Asset Management
- Establish and maintain a Reliability Engineering program focused on maximizing equipment availability, minimizing downtime, and reducing lifecycle costs.
- Develop and monitor key reliability metrics including equipment uptime, schedule compliance, and asset utilization.
- Assist with root cause investigations and corrective actions related to equipment failures, recurring deviations, and operational losses.
- Drive asset lifecycle management strategies to optimize performance, reliability, maintainability, and regulatory compliance.
Maintenance and Facilities Operations
- Provide leadership and oversight for campus maintenance programs, including preventive, predictive, corrective, and emergency maintenance activities.
- Ensure effective execution of work management processes, planning and scheduling systems, spare parts management, and CMMS utilization.
- Lead facility programs including security systems, contractor management, building maintenance, grounds management, housekeeping oversight, pest control, and infrastructure sustainability.
- Ensure facility and utility systems are maintained in a state of inspection readiness and operational reliability.
Manufacturing Automation and Digital Systems
- Lead site manufacturing automation strategy, governance, and execution to support operational excellence and digital transformation initiatives.
- Provide oversight for automation systems including PLCs, SCADA, DCS, HMI, historian platforms, manufacturing data systems, and related computerized systems.
- Partner with Operations, Quality, IT, and MS&T to implement automation solutions that improve process robustness, data integrity, efficiency, and scalability.
- Drive modernization of manufacturing systems through digital technologies, advanced analytics, system integration, and automation lifecycle management.
- Ensure automation systems comply with applicable regulatory requirements, data integrity standards, cybersecurity expectations, and validation requirements.
Metrology and Calibration
- Lead the site metrology function, ensuring effective calibration, maintenance, repair, and lifecycle management of critical instruments and measurement systems.
- Maintain compliant calibration systems that support manufacturing, laboratory, facility, and utility operations.
- Drive continuous improvement initiatives that enhance measurement accuracy, reliability, and operational efficiency.
Business Continuity, Sustainability, and Risk Management
- Lead engineering aspects of business continuity planning, disaster recovery preparedness, infrastructure redundancy, and risk mitigation strategies.
- Support and advance site sustainability and ESG initiatives through energy management, utility optimization, refrigerant stewardship, and environmental improvement projects.
- Assess operational and technical risks and implement mitigation strategies to ensure business continuity and regulatory compliance.
People Leadership
- Directly lead engineering, validation, maintenance, reliability, metrology, and automation leaders and their associated teams.
- Establish clear performance expectations and accountability measures.
- Conduct hiring, performance management, coaching, development, succession planning, and employee engagement activities.
- Ensure all personnel maintain required technical competencies, training qualifications, and compliance requirements.
- Promote a highly engaged, inclusive, and performance-driven culture focused on safety, quality, service, and operational excellence.
Additional Responsibilities
- Independently make strategic and operational decisions impacting site infrastructure, compliance, reliability, and manufacturing capability.
- Utilize data-driven decision making, Lean principles, and continuous improvement methodologies to enhance performance.
- Other duties as assigned.
Qualifications
- Bachelor's degree in Engineering, Chemical, Mechanical, Biochemical, or equivalent required.
- 15+ years of related experience required.
- 6+ years of people leadership experience required.
- Prior pharmaceutical experience required; prior CDMO experience preferred.
Knowledge, Skills, and Abilities
Technical Knowledge
- Expert knowledge of pharmaceutical engineering, facilities, utilities, maintenance, reliability engineering, validation lifecycle management, and manufacturing automation within GMP-regulated environments.
- Advanced knowledge of sterile manufacturing operations, aseptic processing systems, cleanroom operations, and critical utility systems.
- Extensive knowledge of cGMP regulations, FDA, EU GMP Annex 1, ICH, ISPE, ASTM, and industry best practices applicable to pharmaceutical manufacturing facilities.
- Strong understanding of equipment lifecycle management, asset reliability, risk management, and continuous improvement methodologies.
- Advanced knowledge of commissioning, qualification, validation, and computerized system validation (CSV) principles, including FAT, SAT, IQ, OQ, PQ, and ongoing lifecycle management.
- Strong understanding of clean utilities and critical infrastructure systems including HVAC, purified water, WFI, clean steam, compressed gases, and environmental monitoring systems.
- Working knowledge of quality systems including deviations, CAPA, change control, risk assessments, and audit management.
- Knowledge of process control systems, PLCs, SCADA, DCS, HMIs, manufacturing execution systems (MES), historian platforms, and industrial automation technologies.
- Knowledge of data integrity, cybersecurity principles, and validation requirements associated with GMP computerized systems.
- Thorough understanding of metrology, calibration, and measurement system management principles.
Leadership and Business Skills
- Demonstrated ability to develop and execute strategic plans that support site growth, operational excellence, and long-term business objectives.
- Strong leadership capability with proven success building, leading, and developing high-performing technical organizations.
- Excellent business acumen with the ability to align engineering investments, capital expenditures, and operational priorities with business strategy.
- Proven ability to manage complex capital projects and multi-disciplinary technical programs from concept through implementation.
- Ability to identify organizational capability gaps and implement talent development and succession planning strategies.
- Strong change management skills with experience leading organizational transformation and continuous improvement initiatives.
Reliability and Operational Excellence
- Experience utilizing equipment reliability and maintenance performance metrics including equipment uptime, schedule compliance, and asset utilization.
- Strong analytical and root cause investigation skills utilizing structured problem-solving methodologies.
- Proven experience implementing operational excellence, Lean manufacturing, and continuous improvement programs that improve performance, reliability, compliance, and cost effectiveness.
- Ability to leverage data and performance metrics to drive informed business decisions and performance improvements.
Regulatory and Compliance Skills
- Extensive experience supporting regulatory inspections, client audits, and internal quality audits within GMP manufacturing environments.
- Strong understanding of global pharmaceutical regulations and quality expectations for sterile drug product manufacturing.
- Experience developing, executing, and maintaining compliant engineering, maintenance, automation, validation, and calibration programs.
- Ability to interpret and apply regulatory guidance, industry standards, and company procedures to ensure inspection readiness and compliance.
Client and Communication Skills
- Exceptional verbal, written, presentation, and interpersonal communication skills.
- Proven ability to effectively interface with clients, regulatory agencies, auditors, executive leadership, and cross-functional teams.
- Ability to communicate complex technical concepts to diverse audiences at all organizational levels.
- Experience leading technical discussions, due diligence activities, c
About Alcami
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Durham, NC, US
Year founded
1979