Job Summary:

The Plant / Project Engineer is responsible for supporting the design, implementation, and optimization of equipment, utilities, and facility systems within the manufacturing site. This role plays a critical part in planning and executing capital and maintenance projects to ensure reliable operations, regulatory compliance, and continuous improvement. The ideal candidate will have strong project management skills and a solid engineering background in a cGMP-regulated pharmaceutical or biotech environment. This role contributes directly to PolyPeptide’s commitment to delivering exceptional quality and on-time delivery to our customers.

Key Responsibilities:

1. Lead and support capital improvement, equipment installation, utility upgrades, and infrastructure projects from concept through execution.
2. Ensure all engineering activities meet applicable cGMP, safety, and environmental compliance requirements.
3. Provide technical support to manufacturing, maintenance, and quality teams in troubleshooting equipment or process issues.
4. Develop detailed project plans, budgets, and schedules; manage vendors and contractors to meet performance targets.
5. Prepare engineering documentation including design specifications, drawings, change controls, and commissioning/qualification protocols.
6. Assist in maintaining the site’s equipment lifecycle documentation and plant layout drawings.
7. Identify and implement improvements to equipment performance, energy efficiency, and process safety.
8. Collaborate cross-functionally with Quality Assurance, Manufacturing, Facilities, and Validation to ensure operational readiness.
9. Support inspections, audits, and validation activities related to engineering systems and projects.
10. Maintain awareness of new technologies and industry trends relevant to plant operations and project delivery.

Qualifications:

Education & Experience

• Required Education:

• Bachelor’s degree in Mechanical, Chemical, Industrial, or related Engineering discipline.
• Experience:
• 3–7 years of engineering experience in pharmaceutical, biotech, or other regulated manufacturing environment.

Skills & Competencies

• Technical Skills:
• Working knowledge of cGMP regulations, equipment qualification, and validation practices.
• Proven experience in capital project execution, utility systems (e.g., HVAC, water, gases), and process equipment.
• Proficiency with CAD software, project management tools, and Microsoft Office
• Soft Skills:
• Strong analytical, organizational, and communication skills.
• Ability to manage multiple priorities and work collaboratively in a cross-functional team environment.

• Competencies:
  • Project Management
  • Technical Problem Solving
  • Regulatory Compliance (cGMP, safety, environmental
  • Cross-Functional Collaboration
  • Equipment and Process Optimization

Salary: $95K-$110K

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.