POSITIONSUMMARY:
The Project Engineeris responsible fordelivering capital engineering projects across the full project lifecycle, from design and scoping through procurement, installation, commissioning, and qualification. The role ensures projects are delivered safely, on time, within budget, and in compliance with applicable GMP and regulatory standards.
DUTIESANDRESPONSIBILITIES:
- Supportand deliver capital engineering projects from conceptthroughcompletion.
- Support delivery ofproject scope, schedules, and budgets to ensure successful outcomes
- Commission, qualify, andvalidatefacilities, utilities, and/or equipment in assigned projects.
- Assistsin authors, revises, reviews, and completes controlled documents for CQV projects.
- Assiststo review and qualify equipment for commissioning, qualification, and validation activities.
- Supportsto writeandreviewGMP and GDP documents and technical specifications.
- Collaborate with multiple departments on assigned project activities and deliverables.
- Assisttoinitiateand coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ,
- Assistwith project scope, budget, schedule, and risk management.
- Coordinate engineering design, construction, commissionin
- Prepare technical specifications, project documentation, and procurement requirements.
- Ensure projects are delivered safely, compliantly, on time, and within budget.
- Support audits, inspections, and regulatory interactions as required
- Maintain clear, professional communication with all project stakeholders
DEMONSTRATEDCOMPETENCIES:
- Business Development -Identifyand target potential clients. Work in a team environment; develop and execute a plan, in alignment with company vision, mission and strategic plans to engage potential customers.
- Relationship Building– Works with and across formal and informal professional and social networks to build long-term partnerships and connections in the life science industry and Internal team.
- Negotiation Skills– Active listening, needs assessment, and presents visions to build a consensus.
- Analytical Skills– Identifies, researches, anddemonstrateslogical reasoning to communicate critical information.
- Rational Persuasion– Presents key factors, influencing factors, and strategic goals toassiststakeholders inidentifyingsolutions.
- Interpersonal Awareness– Ability to be aware of how actions, ideas, and communication can/doesaffect people and their outcomes.
- Agility– Meetsobjectivesby responding to competing and changing priorities and multiple tasks under inflexible timelines.
Requirements
- Bachelor Degree in Engineering or Science.
- Minimum 3 years’ experiencein commission,qualifyand validating facilitiesor capital projects within a GMP/GxP-regulated environment.
- Knowledge of project management principles, commissioning, qualification, and engineering systems.
- Experience with risk-based CQVapproaches.
- Experience with packing line.
- Hands-on experience executing andfacilitatingFAT, SAT, IQ, OQ, and PQ activities.
- Understanding ofquality systems, risk management, and contract administration.
- Strong stakeholder management, communication, and problem-solving skills.