Plant Process Commissioning Qualification Engineer

Main Responsibilities

• Review and approval of SAT, FAT, Commissioning and Qualification, and Design documentation, protocols, test scripts, reports, assessments.
• Impact assessments, Change Control, Functional Component and Design Review, Design Qualification (DRDQ).
• Protocol and Test Script authoring.
• Continuous improvement authoring updates to site Commissioning and Qualification platform procedures.
• Engineering Change Management process.
• Contractor management.
• Serve as the primary Commissioning and Qualification Engineering interface with project management and project controls functions, supporting contractor budget and schedule performance measurements and reporting.
• Provide strong Commissioning and Qualification focus and oversight for packaging and inspection systems.
• Provide Commissioning and Qualification support for projects focusing on equipment and utilities to support Drug substance processing, Final Filling process, and Inspection and Packaging.
• Review and approve protocols, test scripts, data packs, and reports to ensure consistent high-quality engineering documentation across all assigned projects.
• Audit engineering quality in accordance with site and project level Commissioning and Qualification plans, development qualification, Global Engineering Guidelines, and Quality Operational Qualification Guidelines.
• Update and approve site Commissioning and Qualification platform methods and procedures, ensuring alignment with project lessons learned, GEG updates, and global quality document revisions.
• Support technical engineering staff in the use and documentation of the engineering change management process.
• Execute audit initiatives and remediation activities including action items resulting from internal and external audits, change controls, and deviation remediation as directed by the Plant Process and Commissioning and Qualification Lead and/or Site Project Engineering Lead.
• Manage contract associates as required to support Commissioning and Qualification activities.

Scope and Impact

Your work will directly influence the quality and compliance of engineering documentation across both CAPEX and OPEX projects. By applying Global Engineering Guidelines and local engineering methods, you will ensure that every project meets the highest standards of engineering and regulatory excellence.

• Executing System and Functional Component Criticality Assessments.
• Conducting Design Review and Qualification activities.
• Authoring Protocols, Test Scripts, and Reports as assigned.
• Authoring technical assessments in support of change controls, deviations, and CAPA.

About You

Basic qualifications: Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, Biotechnology, Computer sciences or other related technical fields. 5+ years of experience in Commissioning, Qualification, Testing Equipment, quality assurance, Engineering, Packaging or other related fields.

Additional skills

• Packaging and Inspection process systems.
• Process Equipment, Filling systems, isolators, purification systems, Chromatography systems, autoclaves, washers, and Controlled Temperature Units.
• GMP Utilities: WFI, Clean Steam, Clean Compressed Air.
• Experience in the vaccine or pharmaceutical industry.
• Demonstrated expertise in the quality review of good documentation practices (GDP).
• Knowledge of quality and regulatory requirements applicable to pharmaceutical and biotech manufacturing.
• Experience with contemporary commissioning and qualification methods.