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Due to large scale pharmaceutical project wins we now wish to recruit a Senior CSV Engineer to join our OTS-team based at a client site.
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The candidate will join the client's project within the Commissioning, Qualification & Validation (CQV) environment. The mission is focused on Computer System Validation (CSV) and, most importantly, Data Integrity for GMP systems across multiple project areas including utilities, drug substance, drug product and analytical laboratories.
The primary focus of the role (approximately 80%) is Data Integrity, especially Data Integrity Risk Assessments (DIRA). The mission is planned to start as soon as possible and currently runs until the end of the year, with possible extension.
Team info:
The candidate will work within an integrated cross-functional team involving quality, IT specialists, process data owners, system owners and other project stakeholders. The candidate will collaborate with approximately 10 to 20 stakeholders across various project streams and will act as the key driver for Data Integrity activities while coordinating with multiple functions.
Day to day:
Act as CSV & Data Integrity Subject Matter Expert and compliance lead.
Lead CSV Commissioning & Qualification activities throughout the project lifecycle.
Perform and drive Data Integrity Risk Assessments (DIRA) and gap analyses.
Ensure compliance with 21 CFR Part 11 requirements.
Review and assess:
Audit trails
Electronic records and electronic signatures
System security
Access management
Data import/export processes
Backup and disaster recovery processes
Reporting functionalities
Coordinate with IT and compliance teams for implementation and testing activities.
Support process automation validation activities for EMS, BMS, PCS/DCS and SCADA systems.
Review automation design documentation, configuration verification and testing activities.
Participate in interface testing, IO loop testing, alarm management, interlocks, control loops and trending verification.
Support validation of PLC-controlled equipment including WFI generation, decontamination stations, lab water systems and filling lines.
Draft, review and approve validation documentation, test protocols and final reports.
Drive deviation investigations, troubleshooting and resolution of CSV-related issues.
Review and manage change controls related to CSV and qualification activities.
Ensure training compliance for personnel involved in C&Q activities.
Coordinate stakeholders and actively drive deliverables to completion.
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This is a senior expert role where the candidate is expected to act as a Subject Matter Expert, providing leadership, guidance and driving Data Integrity and CSV activities from design through execution and final approval.
Minimum 8-10 years of relevant experience preferred.
At least 5+ years of experience as CSV/Data Integrity Lead, SME or senior expert within international CAPEX projects.
Strong pharmaceutical or biotechnology industry experience is considered mandatory.
Proven experience delivering CSV Commissioning & Qualification activities in GMP-regulated environments.
Must have:
Expert-level knowledge of Data Integrity principles.
Strong hands-on experience with DIRA execution and gap analysis.
Deep knowledge of 21 CFR Part 11.
Extensive CSV Commissioning & Qualification experience.
Pharmaceutical and/or biotechnology industry experience.
Experience with GMP-regulated systems and environments.
Strong understanding of risk-based CSV approaches.
Knowledge of:
GAMP 5
ISPE best practices
Annex 15 GMP EU
Annex 1 GMP
ASTM E2500
Experience reviewing audit trails, electronic records and electronic signatures.
Ability to lead stakeholders and drive activities independently.
Strong communication and leadership skills.
Ability to collaborate with senior stakeholders.
Hands-on mindset with the ability to hit the ground running.
Technical degree in Engineering or equivalent qualification.
Fluent professional English.
Nice to have:
Experience with process automation systems (EMS, BMS, DCS, SCADA).
Experience with PLC-controlled GMP equipment.
Exposure to inspections and presenting Data Integrity topics during audits.
Experience with sterile, biotech and single-use technologies.
French language skills. (not mandatory but an advantage)
Experience with electronic execution environments.
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