Job Description Role: Project Engineer – C Q (Commissioning Qualification) Contract: 24 months (initial 12-month) Location: Eastern Midland Region, Ireland (on-site) Role Summary: Serve as Occupli's client-representative within the Global Engineering Team, providing project engineering support for commissioning and qualification of a drug substance / drug product manufacturing facility.
You will help manage cross-functional teams to deliver key C Q milestones.
Key Responsibilities: Develop and maintain project schedules, work plans, and cost-tracking for equipment and capital.
Coordinate across stakeholders including engineering, validation, quality, operations, and vendors.
Lead installation, start-up, and testing through Operational Qualification (OQ).
Support readiness for post-OQ phases (PQ, PPQ), ensuring design and validation deliverables reflect site and business requirements.
Monitor project progress, costs, and risks; produce tiered status reporting.
Engage with cross-functional experts, SMEs, and vendor partners to ensure alignment.
Assist in regulatory and validation documentation, including CAPAs and risk assessments.
Drive continuous improvement in C Q execution and handover processes.
Requirements Requirements: Bachelor's or Master's degree in Engineering (Mechanical, Process, Chemical, etc.).
Minimum 6 years' experience in a commissioning / qualification / validation role — ideally in a sterile or aseptic manufacturing environment.
Experience writing and executing IQ/OQ (and preferably PQ) protocols.
Strong project coordination, communication and stakeholder engagement skills.
Demonstrated ability to collaborate cross-functionally and work as part of a team.
Desirable (but not essential): Knowledge of GMP, risk-based validation (e.g. FMEA), and ISPE / GAMP frameworks.
Experience with FAT / SAT, vendor management, and commissioning change control.
Why Work With Us / Benefits: Work on a high-impact project in a leading pharmaceutical manufacturing facility.
Be part of an international engineering team and contribute to critical qualification phases.
Gain contract-based flexibility with the opportunity to make a measurable difference.
Opportunity to deepen your expertise in pharma commissioning validation .
Requirements Requirements: Bachelor's or Master's degree in Engineering (Mechanical, Process, Chemical, etc.).
Minimum 6 years' experience in a commissioning / qualification / validation role — ideally in a sterile or aseptic manufacturing environment.
Experience writing and executing IQ/OQ (and preferably PQ) protocols.
Strong project coordination, communication and stakeholder engagement skills.
Demonstrated ability to collaborate cross-functionally and work as part of a team.
Desirable (but not essential): Knowledge of GMP, risk-based validation (e.g. FMEA), and ISPE / GAMP frameworks.
Experience with FAT / SAT, vendor management, and commissioning change control.
Why Work With Us / Benefits: Work on a high-impact project in a leading pharmaceutical manufacturing facility.
Be part of an international engineering team and contribute to critical qualification phases.
Gain contract-based flexibility with the opportunity to make a measurable difference.
Opportunity to deepen your expertise in pharma commissioning