Mechanical Engineer

REQUIRED SKILLS AND EXPERIENCE:

• 7 years of experience in mechanical engineering
• Pharma or biotech industry background
• Knowledge of clean and dirty utilities, autoclaves, and parts washers in a GMP environment
• Experience with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities

NICE TO HAVE SKILLS AND EXPERIENCE:

• Capital project experience

JOB DESCRIPTION:

We are seeking an experienced Mechanical Project Engineer to support a Large Pharmaceutical Capital project. This role will focus on Engineering design, procurement, startup, vendor management, commissioning, and qualification. The ideal candidate will have experience with mechanical systems, including clean and dirty utilities as well as autoclaves and parts washers. The Mechanical Project Engineer will be responsible for reviewing engineering submittals and drawings, reviewing and responding to RFIs, supporting infield execution and startup of mechanical systems, and Engineering closeout, including following resolution of punch list items and final review and approval of Engineering Turnover Packages (ETOPs) to ensure compliance with project requirements and industry standards. The candidate should also have strong organizational skills, and excellent communication abilities to collaborate effectively with cross-functional teams and vendors.

Engineering Design & Execution:

- Oversee Mechanical Engineering, ensuring GMP compliance.

- Provide technical expertise for mechanical systems.

- Review and approve engineering submittals.

- Review drawings and specifications, resolving discrepancies.

- Respond to RFIs and support design reviews and risk assessments.

Vendor & Stakeholder Management:

- Manage relationships with vendors, contractors, and suppliers.

- Validate vendor submittals and collaborate with cross-functional teams.

- Coordinate Site Acceptance Testing (SAT).

Project Coordination & Instrument Implementation:

- Oversee planning and execution of mechanical system implementation.

- Maintain project schedules and ensure timely delivery.

- Collaborate with internal stakeholders for smooth execution.

Startup, Commissioning & Qualification:

- Support startup and commissioning plans.

- Support IQ, OQ, and PQ activities.

- Ensure adherence to cGMP, FDA, and company standards.

- Facilitate punch list generation and resolution.

Project Support & Problem-Solving:

- Provide technical troubleshooting and resolution.

- Identify and mitigate risks.

- Ensure proper documentation of engineering activities.

Compliance, Documentation & Reporting:

- Ensure installations and qualifications meet regulatory standards.

- Maintain detailed project records.

- Assist in SOP development and provide status updates to leadership.