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 adrug substance / drug product manufacturing facility.
You will help managecross-functional teams to deliver key C&Q milestones.
Key Responsibilities
Developand maintain project schedules, work plans, and cost-tracking forequipment and capital.
Coordinateacross stakeholders including engineering, validation, quality,operations, and vendors.
Leadinstallation, start-up, and testing through Operational Qualification(OQ).
Supportreadiness for post-OQ phases (PQ, PPQ), ensuring design and validationdeliverables reflect site and business requirements.
Monitorproject progress, costs, and risks; produce tiered status reporting.
Engagewith cross-functional experts, SMEs, and vendor partners to ensurealignment.
Assistin regulatory and validation documentation, including CAPAs and riskassessments.
Drivecontinuous improvement in C&Q execution and handover processes.
Requirements
Bachelor'sor Master's degree in Engineering (Mechanical, Process, Chemical, etc.).
Minimum6 years' experience in a commissioning / qualification / validation role —ideally in a sterile or aseptic manufacturing environment.
Experiencewriting and executing IQ/OQ (and preferably PQ) protocols.
Strongproject coordination, communication and stakeholder engagement skills.
Demonstratedability to collaborate cross-functionally and work as part of a team.
Desirable (but not essential)
Knowledgeof GMP, risk-based validation (e.g. FMEA), and ISPE / GAMP frameworks.
Experiencewith FAT / SAT, vendor management, and commissioning change control.
Benefits
Workon a
high-impact project
in a leading pharmaceutical manufacturingfacility.
Bepart of an
international engineering team
and contribute tocritical qualification phases.
Gain
contract-based flexibility
with the opportunity to make ameasurable difference.
Opportunityto deepen your expertise in
pharma commissioning & validation
.
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