Job Title: Plant Process Commissioning Qualification Engineer
About the Job
The Plant Process Commissioning Qualification Engineer is a critical engineering quality review and execution support role responsible for the consistent application governance and maintenance of Commissioning and Qualification Engineering platform procedures In this role you will apply Commissioning and Qualification testing templates engineering standards and specifications across both OPEX and CAPEX projects You will directly support antigen and filling manufacturing operations with a strong emphasis on Inspection and Packaging processes work that ultimately protects patients and ensures the integrity of life saving vaccines and pharmaceutical products.
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
This role offers a dynamic blend of technical leadership quality governance and cross functional collaboration.
As a key member of our engineering team, you will
- 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 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 Specific activities include
- 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
North America Applicants Only
The salary range for this position is:
$85.500,00 - $123.500,00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can
