Valsource

Description Overview:

ValSource is currently looking to find bright, enthusiastic and experienced leaders in Process Engineering to support exciting GMP Drug Substance and Drug Product capital projects throughout our network. These individuals will be empowered to lead teams and equipment packages, throughout the full project lifecycle—from design and installation through commissioning, qualification, and startup. This is a key part of strengthening ValSource's growing role in front-end Process Design Engineering and enabling end-to-end support for our clients with expert engineers engaged throughout our projects. ValSource are committed to the development and growth for the hired individual/s to broaden their expertise in unit operations and different areas of Process Engineering.

Primary Responsibilities

• Reporting to ValSource's and our client’s Process Engineering Manager, while demonstrating independent drive and sound judgment in day-to-day operations at the client site. The individual will work closely with a mentor ValSource Process Engineer.
• Lead day-to-day tactical vendor coordination: on-site logistics, and field testing.
• Manage multidisciplinary teams with representatives from Process Engineering, Automation, Commissioning, Qualification & Validation (CQV) and others to drive projects through capital management phases from Concept Design, through Detailed Design and Execution.
• Collaborate effectively with client Subject Matter Experts (SMEs) for critical design decisions.
• Demonstrate strong organization, technical writing and communication skills.
• Manage quality, schedule and cost within prescribed project limits.
• Provide clear technical leadership and expertise to lead teams through Safety assessments (PHA, HAZOP and LOPA), Ergonomic and Quality assessments (Development of CIP/SIP strategy, Automation development and GMP Design review). Gather internal and external stakeholder requirements and communicate clear owner's intent, ensure stakeholders are aligned or if not, elevate issues for rapid decision making.
• Ensure the thorough completion of the following process‑specific activities:
• Vendor collaboration: build productive relationships to deliver complex equipment in a timely manner.
• Listen and translate clients' operational requirements to a hard design; document these needs in User Requirements and Equipment Specifications to onboard a Vendor.
• Review vendor design specifications and submittals to ensure compliance with client requirements and industry best practices in the physical design.
• Ensure clear communication and prioritization of needs for Structural, Civil, HVAC, Electrical & Construction groups.
• Lead on site SAT/IOC/IOQ execution at Vendor and client sites. Act as facilitator, supervisor and Safety lead ensuring client Safety and Quality standards are upheld.
• Lead and oversee Execution phase for the Process Team with CQV team, ensuring thorough testing of all requirements and demonstration of system functionality.

Other Key Responsibilities

Serve as Process Engineer and lead scope within the following equipment areas:

• Reactor systems
• Glovebox containment systems
• Potent Charge Isolators systems
• Single use systems
• API equipment (Temperature Control Modules, Analytical Laboratory, Process Collection and Containment equipment)

Requirements Candidate Qualifications / Experience Required:

• Bachelor’s and/or Masters degree in engineering or related field.
• 5+ years of experience in pharmaceutical or biotech manufacturing industry with a preference for experience in capital projects.
• Strong working knowledge of GMP systems, API, potent containment, equipment qualification, and process operations. Field experience troubleshooting equipment is sought after.
• Proven ability to lead teams, manage stakeholders, to improvise and explain/resolve process engineering design issues
• Excellent communication, problem-solving, and organizational skills.
• Field: Factory Acceptance Testing (FAT) and/or Site Acceptance Testing (SAT) and hands on equipment experience preferred. Looking for engineers with experience working, troubleshooting equipment.
• Process Design: Experience in API/Reactors preferred.
• Automation: Delta V or PLC experience for Automation phases, CIP, etc.
• Project Management Skills: Ability to independently manage multiple team members or vendors in sourcing, procurement, design, and can lead a meeting with authority and drive issues to closure with teams.

Location:

Rahway, NJ

Onsite Requirements:

This is an onsite role. The project is in the late-phase construction phase.

Other Information

This is a full-time position with ValSource. As such, we are not considering applications from employment agencies, independent contractors, or third-party vendors. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification forms upon hire.

Benefits

• Benefits of full-time employment with ValSource will include:
• Paid Time Off (PTO) and Holidays
• Medical / Dental / Vision Insurance - premiums 100% paid by ValSource for Employee to Family level coverage
• Basic Life / Short- and Long-Term Disability / Voluntary Life / AD&D Insurance coverages
• ValSource 401(k) Plan
• ValSource Employee Stock Ownership Plan (ESOP)
• Paid Maternity / Paternity
• Medical Leave Pay
• Tuition Reimbursement / Continuing Education
• Annual Performance Bonus Compensation

About ValSource

ValSource is one of the largest independent Validation Services Company in North America with over 350 Engineering, Commissioning, Qualification and Validation employees. ValSource returns validation to a scientific event which helps companies design, perform and better control manufacturing processes throughout all stages of the operations life cycle. Full-time employees are offered a competitive compensation package that also includes full benefits (medical, dental, vision, short- and long-term disability), 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan, discretionary bonus, etc.

Equal Employment Opportunity

ValSource provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, genetic information, military, and veteran status.