A C&Q/CSV Specialist responsible for ensuring compliance with regulatory requirements, GMP, and pharmaceutical policies through commissioning, qualification, and computer systems validation activities.
Responsibilities
Ensure the site validation program has been developed and maintained in compliance with regulatory and corporate requirements and Master Plans.
Work with qualification teams on requirement, design review, construction, qualification, and documentation strategies.
Review and approve commissioning and qualification documentation, including URS, IQ, OQ, and PQ protocols and reports, SOPs, and Work Instructions.
Review and approve validation protocols and reports (analytical, cleaning, process, etc.).
Provide quality oversight for C&Q/CSV and validation execution activities to ensure compliance with GMP, FDA, EMA, and regulatory requirements.
Requirements
Bachelor's degree in a scientific or engineering discipline
Lead and own the company’s G&A application portfolio, including NetSuite ERP, ADP HRIS, LMS, financial planning, procurement, expense, contract lifecycle management and corporate tools, while ensuring SOX IT general controls.
Locations (2)
Bedford, Massachusetts, United States
Waltham, Massachusetts, United States
Compensation
The anticipated salary range for this role is $260,000 - $305,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.
Responsibilities
Lead the NetSuite extension program for commercial launch
Own the roadmap and day-to-day operations for NetSuite, ADP and the G&A applications
Own the LMS platform in partnership with HR, Legal, Compliance and Marketing/L&D
Serve as IT partner to Finance, HR, Legal, Compliance, Procurement and Internal Audit
Drive continuous improvement and streamline G&A business processes
Requirements
E
Risk Consulting - Enterprise Risk - Sr Manager - Life Sciences - Regulatory Affairs
Senior Manager to lead EY’s Life Sciences Regulatory Submissions practice, driving growth and establishing EY as a leader in the Regulatory Compliance sector.
Locations (10)
New York, New York, United States
Atlanta, Georgia, United States
Boston, Massachusetts, United States
Chicago, Illinois, United States
Dallas, Texas, United States
Manager, Engineering Computer Systems Validation (CSV)
Lead the CSV programme across MPCC and SDPF facilities, managing strategy, planning, and compliance for computerised systems in a GMP-regulated biologics environment.
Compensation
You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym
Responsibilities
Lead the CSV programme across MPCC and SDPF, reporting progress and escalations to the Sr. Manager, Engineering CQV
Develop and maintain the CSV strategy, validation master plan, and risk-based approaches in line with GAMP 5, 21 CFR Part 11, and EU Annex 11
Plan, coordinate, and oversee CSV activities across the full system lifecycle, ensuring timely completion and adherence to budget
Oversee the authoring, review, and approval of CSV deliverables, including validation plans, user and functional requirements, risk assessments, configuration and design specifications, test protocols (IQ/OQ/PQ), traceability matrices, SOPs, and summary reports
Ensure data integrity compliance (ALCOA+) across all validated computerised systems, including process control, laboratory, manufacturing execution, and enterprise systems
Requirements
Bachelor's or Master's degree in Engineering, Computer Science, Life Sciences, or a related discipline
Nice to have: DeltaV
Nice to have: MES
Nice to have: SAP
Nice to have: laboratory and building management systems
Senior Specialist, Engineering Commissioning, Qualification and Validation (CQV)
Lead qualification and validation of process and utility equipment and computerised systems across BMS’s MPCC and SDPF facilities.
Compensation
You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym
Responsibilities
Plan and execute risk-based protocols for equipment and systems
Author and manage IQ, OQ, PQ protocols and CSV deliverables
Ensure compliance with regulatory requirements and industry standards
Maintain audit-ready validation documentation
Support regulatory inspections and root cause analysis
Requirements
Bachelor's degree in Engineering, Life Sciences, Chemistry or a related field
Nice to have: biologics or pharmaceutical manufacturing experience
Nice to have: biologics start-up facility familiarity
Lead qualification and validation of process and utility equipment and computerised systems across the MPCC and SDPF facilities.
Compensation
You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym
Responsibilities
Develop commissioning, qualification and validation plans and risk-based strategies for new and existing process and utility equipment and computerised systems.
Author, execute and report IQ, OQ and PQ protocols for equipment, including functional testing, troubleshooting and support for start-up activities.
Author and manage CSV deliverables across the system lifecycle in line with GAMP 5, including URS, FS, DS, IQ/OQ/PQ and traceability matrices.
Ensure computerised systems comply with 21 CFR Part 11, EU Annex 11 and data integrity requirements.
Ensure all qualification and validation activities meet applicable regulatory requirements (FDA, EMA, ICH) and industry standards (GAMP 5, ASTM).
Requirements
Bachelor's degree in Engineering
Bachelor's degree in Life Sciences
Bachelor's degree in Chemistry
Nice to have: experience in biologics or pharmaceutical manufacturing
Nice to have: experience in a biologics start-up facility
The role takes ownership of the qualification of process and utility equipment and the validation of the computerised systems that control it, from commissioning and start-up through to routine operation at the Multi-Product Cell Culture (MPCC) and Sterile Drug Product Facility (SDPF) sites.
Compensation
competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym
Responsibilities
Work as part of the Engineering CQV team under a campus approach, supporting commissioning, qualification and validation activities across both the MPCC and SDPF facilities.
Develop commissioning, qualification and validation plans and risk-based strategies for new and existing process and utility equipment and computerised systems.
Author, execute and report IQ, OQ and PQ protocols for equipment, including functional testing, troubleshooting and support for start-up activities.
Author and manage CSV deliverables across the system lifecycle in line with GAMP 5, including URS, FS, DS, IQ/OQ/PQ and traceability matrices.
Ensure computerised systems comply with 21 CFR Part 11, EU Annex 11 and data integrity requirements.
Requirements
Bachelor's degree in Engineering, Life Sciences, Chemistry or a related field
Nice to have: biologics manufacturing environment
Nice to have: pharmaceutical manufacturing environment
Senior Director, Enterprise ApplicationsStoke Therapeutics · Bedford, US+1 more
Manager, Engineering Computer Systems Validation (CSV)Bristol Myers Squibb · Ireland