Overview:
As a Project Engineer, you will be responsible for the design, specification, and commissioning of new and modified biopharmaceutical process systems and clean utility equipment. You will provide technical engineering support across projects, lead investigations into equipment and process deviations, and play a key role in project execution. You will work closely with Project Managers to ensure that project objectives—such as operational income, execution plans, and customer satisfaction—are met or exceeded.
Key Responsibilities:
1. Collaborate in a professional, team-oriented office environment to meet deadlines and deliver on customer commitments.
2. Keep Project Managers, team members, and departmental leadership regularly informed on project status, needs, and progress.
3. Identify and communicate changes in scope that could impact project costs.
4. Act as the primary technical contact for customers on assigned projects.
5. Support Project Managers when needed, including in their absence.
6. Contribute to the achievement of departmental goals, objectives, and performance metrics.
7. Interpret and analyze customer specifications and proposal documents.
8. Assess customer requirements relative to the company's scope of supply and commercial terms.
9. Maintain project and contract documentation in line with company standards.
10. Collaborate with Designers to ensure deliverables meet form, fit, and function requirements.
11. Support and review critical engineering documentation (e.g., P&IDs, general arrangements, detailed drawings, BOMs).
12. Perform technical calculations for equipment sizing and verification.
13. Develop specifications and data sheets for process equipment.
14. Participate in design verification activities, including design model reviews.
15. Review and approve Engineering Change Notices (ECNs) to ensure accuracy before release.
16. Support Automation and Electrical Engineers to meet equipment functionality and integration requirements.
17. Assist in developing and approving automation documents such as Functional Requirements Specifications (FRS) and Detailed Design Specifications (DDS).
18. Collaborate with Manufacturing and Quality teams to ensure engineering deliverables meet customer standards during fabrication and qualification.
19. Provide technical oversight for projects in fabrication and quality verification phases.
20. Lead and/or support Pre-FAT, FAT, and SAT activities both domestically and internationally.
21. Create and gain customer approval for test plans and qualification protocols.
22. Develop and deliver IQ/OQ documentation as required.
23. Contribute to the creation and improvement of engineering standards, procedures, and best practices.
24. Identify opportunities for cost reduction and process improvement; actively participate in improvement initiatives.
25. Travel to customer sites as needed.
26. Perform additional duties as assigned.
Qualifications:
1. Bachelor's Degree (Level 8) in Mechanical, Biological, Chemical Engineering, or a related discipline.
2. Minimum of 3 years' post-graduate engineering experience in a relevant industry.
3. Ideally 5+ years of experience in the biopharmaceutical or process equipment sector, including design, fabrication, and testing of custom systems based on client specifications.
4. Preferred 2 years' experience supporting automation and control systems related to bioprocessing equipment.
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