Job Title: Project Engineer
Responsibilities
- Lead the planning, execution, and support of capital and expense projects, including installation, commissioning, and qualification of new or upgraded facilities, utilities, and equipment.
- Conduct equipment and process reviews; prepare technical reports; recommend process improvements or cost-reduction strategies.
- Develop and manage user requirement specifications (URS), technical specifications, and design documentation for new or replacement equipment.
- Oversee project execution, change control management, and coordination of internal and external stakeholders.
- Prepare and execute equipment qualification protocols (IQ/OQ).
- Monitor and report project status, timelines, and costs, ensuring alignment with defined targets.
- Coordinate with cross-functional teams (operations, maintenance, EHS, QA, materials, development) to minimize production impact.
- Comply with company SOPs, safety policies, regulatory standards, and industry codes.
- Adhere to productivity targets and escalation protocols for deviations or production-impacting issues.
- Complete all required training and follow established safety and compliance procedures.
- May participate in departmental initiatives and travel for equipment selection and Factory Acceptance Tests (FATs).
Requirements
- Bachelor’s Degree in Engineering or equivalent combination of education and relevant experience.
- 3–5 years of experience in engineering roles, preferably within pharmaceutical or life sciences manufacturing.
- Familiarity with pharmaceutical manufacturing and packaging equipment; experience with process equipment design and specification is an advantage.
- Strong understanding of P&IDs, process flow diagrams, and related commissioning and qualification documentation.
- Experience with pharmaceutical processing technologies and 21 CFR Part 11-compliant cGMP systems.
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