IT/OT Systems Engineer
$90K - $131K/yr
Coordinate with Digital Quality and Computer System Validation teams to generate and implement lifecycle documentation and validation protocols. Build relationships and collaborate with Manufacturing ...
$90K - $131K/yr
Coordinate with Digital Quality and Computer System Validation teams to generate and implement lifecycle documentation and validation protocols. Build relationships and collaborate with Manufacturing ...
$90K - $131K/yr
Coordinate with Digital Quality and Computer System Validation teams to generate and implement lifecycle documentation and validation protocols. Build relationships and collaborate with Manufacturing ...
$90K - $131K/yr
Coordinate with Digital Quality and Computer System Validation teams to generate and implement lifecycle documentation and validation protocols. * Build relationships and collaborate with ...
$90K - $131K/yr
Coordinate with Digital Quality and Computer System Validation teams to generate and implement lifecycle documentation and validation protocols. * Build relationships and collaborate with ...
$15.50 - $19/hr
Able to use computer system * Valid drivers' license and clean driving record
$15.50 - $19/hr
Able to use computer system * Valid drivers' license and clean driving record
$95K - $99K/yr
Elicit, document, and validate business and system requirements in collaboration with program, IT ... computer system, requires 24 mos. recent exp. (i.e., within past 5 years) in delivery of human ...
$95K - $99K/yr
Elicit, document, and validate business and system requirements in collaboration with program, IT ... computer system, requires 24 mos. recent exp. (i.e., within past 5 years) in delivery of human ...
Ensure systems remain in a validated state through periodic review, revalidation, and change ... COMPUTER SKILLS: Ability to use and understand Windows Office Suite (Word, Excel, PowerPoint ...
Ensure systems remain in a validated state through periodic review, revalidation, and change ... COMPUTER SKILLS: Ability to use and understand Windows Office Suite (Word, Excel, PowerPoint ...
West Chester, OH · On-site
$90K - $131K/yr
... Computer System Validation teams to generate and implement lifecycle documentation and validation protocols. • Build relationships and collaborate with Manufacturing, Technical Operations ...
West Chester, OH · On-site
$90K - $131K/yr
... Computer System Validation teams to generate and implement lifecycle documentation and validation protocols. • Build relationships and collaborate with Manufacturing, Technical Operations ...
Knowledge of computer system validation (CSV). * Familiarity with FDA 21 CFR Part 11, Good Manufacturing Practices (GMP), Good Automated Manufacturing Practice (GAMP), and ISA88 Batch Control.
Knowledge of computer system validation (CSV). * Familiarity with FDA 21 CFR Part 11, Good Manufacturing Practices (GMP), Good Automated Manufacturing Practice (GAMP), and ISA88 Batch Control.
Knowledge of computer system validation (CSV). * Familiarity with FDA 21 CFR Part 11, Good Manufacturing Practices (GMP), Good Automated Manufacturing Practice (GAMP), and ISA88 Batch Control.
Knowledge of computer system validation (CSV). * Familiarity with FDA 21 CFR Part 11, Good Manufacturing Practices (GMP), Good Automated Manufacturing Practice (GAMP), and ISA88 Batch Control.
New Albany, OH · On-site
$85K - $115K/yr
... Computer System Validation (CSV), IT/OT, and external cold room vendors to deliver reliable, scalable, and compliant cold chain solutions. Key Responsibilities · Lead the design of cold room and ...
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New Albany, OH · On-site
$85K - $115K/yr
... Computer System Validation (CSV), IT/OT, and external cold room vendors to deliver reliable, scalable, and compliant cold chain solutions. Key Responsibilities · Lead the design of cold room and ...
Cleveland, OH · On-site
$33K - $70K/yr
Troubleshoots computer system problems and provides other technical assistance as needed. Performs ... Valid state of Ohio Driver's License is required. WATER (CONTROL SYSTEMS) - High School Diploma or ...
Cleveland, OH · On-site
$33K - $70K/yr
Troubleshoots computer system problems and provides other technical assistance as needed. Performs ... Valid state of Ohio Driver's License is required. WATER (CONTROL SYSTEMS) - High School Diploma or ...
Cleveland, OH · On-site
Project Leadership - Act as technical SME in cross-functional M&A integration teams. - Develop and maintain migration runbooks, rollback plans, and post-migration validation checklists. - Provide ...
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Cleveland, OH · On-site
Project Leadership - Act as technical SME in cross-functional M&A integration teams. - Develop and maintain migration runbooks, rollback plans, and post-migration validation checklists. - Provide ...
Executes approvals within the change control process of the following quality systems: cleaning validation, computer validation, equipment validation, process validation, analytical validation, and ...
Executes approvals within the change control process of the following quality systems: cleaning validation, computer validation, equipment validation, process validation, analytical validation, and ...
Columbus, OH · On-site
They provide support to resolve system issues within Service Level Agreements. Duties ... Recruiting agencies must have a valid, written and fully executed Master Service Agreement and ...
Columbus, OH · On-site
They provide support to resolve system issues within Service Level Agreements. Duties ... Recruiting agencies must have a valid, written and fully executed Master Service Agreement and ...
Columbus, OH · On-site
They provide support to resolve system issues within Service Level Agreements. Duties ... Recruiting agencies must have a valid, written and fully executed Master Service Agreement and ...
Columbus, OH · On-site
They provide support to resolve system issues within Service Level Agreements. Duties ... Recruiting agencies must have a valid, written and fully executed Master Service Agreement and ...
Dayton, OH · On-site
$60 - $80/hr
... systems perform reliably in demanding real-world environments. Role Overview The Lead Electronic ... Key Responsibilities Validation Planning and Strategy - Develop and maintain DVP&R plans ...
Dayton, OH · On-site
$60 - $80/hr
... systems perform reliably in demanding real-world environments. Role Overview The Lead Electronic ... Key Responsibilities Validation Planning and Strategy - Develop and maintain DVP&R plans ...
Ensure compliance of Medpace computer systems with GxP and SOx regulatory requirements; * Ensure compliance of system validation Standard Operating Procedures (SOPs) with regulatory requirements;
Ensure compliance of Medpace computer systems with GxP and SOx regulatory requirements; * Ensure compliance of system validation Standard Operating Procedures (SOPs) with regulatory requirements;
Canton, OH · On-site
Provide product validation support for: * The development of new products * The modification of ... Ability to use computer software for plotting and curve fitting is necessary. * Experience using a ...
Canton, OH · On-site
Provide product validation support for: * The development of new products * The modification of ... Ability to use computer software for plotting and curve fitting is necessary. * Experience using a ...
Ensure compliance of Medpace computer systems with GxP and SOx regulatory requirements; * Ensure compliance of system validation Standard Operating Procedures (SOPs) with regulatory requirements;
Ensure compliance of Medpace computer systems with GxP and SOx regulatory requirements; * Ensure compliance of system validation Standard Operating Procedures (SOPs) with regulatory requirements;
$100K - $131K/yr
Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Serve as a recognized Engineering Subject Matter Expert (SME ...
$100K - $131K/yr
Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Serve as a recognized Engineering Subject Matter Expert (SME ...
Columbus, OH · On-site
$100K - $131K/yr
Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Serve as a recognized Engineering Subject Matter Expert (SME ...
Columbus, OH · On-site
$100K - $131K/yr
Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Serve as a recognized Engineering Subject Matter Expert (SME ...
$10.06 - $16.58
2% of jobs
$16.58 - $23.10
9% of jobs
$23.10 - $29.63
1% of jobs
$29.63 - $36.15
4% of jobs
$40.11 is the 25th percentile. Wages below this are outliers.
$36.15 - $42.67
15% of jobs
$42.67 - $49.20
9% of jobs
The median wage is $54.63 / hr.
$49.20 - $55.72
13% of jobs
$60.92 is the 75th percentile. Wages above this are outliers.
$55.72 - $62.24
29% of jobs
$62.24 - $68.77
12% of jobs
$68.77 - $75.29
2% of jobs
$75.29 - $81.81
5% of jobs
$10
$51
$81
Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.
A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.
To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

$90K - $131K/yr
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 6 days ago
A career at Resilience is more than just a job - it's an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
The Manufacturing Systems Engineer will work with manufacturing, supply chain, quality and other key
stakeholders to define the requirements for the next generation of manufacturing systems
implementation. This includes leading the specification, configuration, administration, and maintenance of the manufacturing systems platforms. The incumbent will be a key collaborator within the Digital team to ensure integrations of all required systems is achieved.
Job Responsibilities (Including Key Result Areas, Specific Accountabilities, Tasks, Etc.)
Execute the Digital vision and strategy around manufacturing systems across the Resilience
manufacturing network.
Designs, specifies, and supports the manufacturing systems platforms, including implementing
modifications to improve operational performance and product quality.
Analyze, recommend, and implement manufacturing systems projects and enhancements across
the Resilience manufacturing network, with focus on manufacturing execution, automation
techniques and equipment integration.
Supports automation activities throughout technology transfer into the manufacturing network and
provides continued support throughout manufacturing campaigns.
Develop, modify, and redline requirements/specifications related to integration of
Biomanufacturing Automation platforms (e.g., equipment, software, P&ID, network topology,
PFD)
Provide Subject Matter Expert support to Manufacturing, Technical Operations, and other
departments for the design and operation of manufacturing systems platforms.
Coordinate with Digital Quality and Computer System Validation teams to generate and
implement lifecycle documentation and validation protocols.
Build relationships and collaborate with Manufacturing, Technical Operations/Engineering,
Manufacturing Science/Strategy & Technology, and Quality organizations.
Education, Qualifications, Skills, and Experience
Minimum Requirements
Experience in manufacturing operational technology (OT) environments, preferably life sciences.
Tactical knowledge of digital automation systems such as Distributed Control System (DCS) and Programmable Logic Controller (PLC) configuration, field instrumentation installation and troubleshooting, as well as process control experience.
Demonstrated ability to handle multiple competing priorities and projects in a fast-paced environment with a proven track record for delivering results on large, cross functional, global projects.
Hands-on experience with IT change management across domains (security, software, network, hardware, etc.)
Fluid collaboration skills across business, IT, and external vendors/suppliers.
Preferred Background
Bachelor of Science degree
Experience with MES integrations to SCADA, ERP, LIMS, and other manufacturing critical systems.
Fluency in supporting the digitization of manufacturing & engineering business process by bringing the IT know-how to business partners in Manufacturing and Technical Operations.
Builder mentality that seeks to produce innovation, agility, and velocity to support business-as usual operations and new project implementation.
Experience with SAP, Pas/X, Veeva, Process Control Networks, Active Directory
Experience in project management, with a strong understanding of timelines, deliverables, and commitments.
Sponsorship or support for work authorization, including visas, is not available for this position.
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $90,000.00 - $131,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.