Job Description
IntePros is seeking an experienced Mechanical Project Engineer to support a client with 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, autoclaves, and parts washers. This position requires strong organizational skills and excellent communication abilities to collaborate effectively with cross-functional teams and vendors.
The Mechanical Project Engineer will be responsible for:
- Reviewing engineering submittals and drawings
- Responding to RFIs
- Supporting in-field execution and startup of mechanical systems
- Managing Engineering closeout, including resolution of punch list items and final review and approval of Engineering Turnover Packages (ETOPs)
Responsibilities
- Oversee mechanical engineering aspects of the project, ensuring compliance with GMP regulations and industry best practices.
- Provide technical expertise in the design and integration of mechanical systems.
- Review and approve engineering submittals from vendors and contractors.
- Review mechanical drawings, P&IDs, and specifications, identifying discrepancies and providing resolutions.
- Respond to RFIs, ensuring clarity and accuracy in engineering documentation.
- Support design reviews and risk assessments to ensure all mechanical systems meet GMP, FDA, and client standards.
- Manage relationships with equipment vendors, construction teams, contractors, and suppliers, ensuring timely delivery and compliance with project requirements.
- Review and validate vendor submittals, including material certifications, technical data sheets, and performance guarantees.
- Collaborate with cross-functional teams, including process engineers, operations, facilities, quality, validation, and construction.
- Participate in and coordinate Site Acceptance Testing (SAT) for critical mechanical equipment.
- Oversee the planning, coordination, execution, and completion of mechanical system implementation in alignment with the capital project timeline.
- Develop and maintain project schedules, ensuring timely delivery, installation, commissioning, and qualification of mechanical systems.
- Work closely with quality, validation, procurement, facilities, and metrology teams.
- Support the development and execution of startup and commissioning plans for mechanical systems.
- Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Ensure all commissioning and qualification activities adhere to cGMP, FDA, and client quality policies.
- Facilitate punch list generation, review, and resolution before system handover.
- Provide technical troubleshooting and resolution for mechanical system challenges.
- Identify and mitigate risks related to system performance, compliance, and reliability.
- Ensure proper documentation of all engineering activities, including change control and validation protocols.
- Ensure all installations and qualifications meet FDA, USP, ICH, and regulatory standards.
- Maintain detailed project records, including vendor interactions, qualification protocols, deviations, and corrective actions.
- Assist in developing and revising Standard Operating Procedures (SOPs) related to system operation, maintenance, and qualification.
- Provide regular project updates to leadership, highlighting risks and mitigation strategies.
Education and Experience Requirements
- Minimum 7 years of mechanical engineering experience in pharmaceutical or biotech industries.
- Extensive knowledge of clean and dirty utilities, autoclaves, and parts washers in a GMP environment.
- Strong background in engineering reviews, commissioning, qualification, and validation.
- Experience managing RFIs, vendor submittals, engineering drawings, and turnover documentation.
- Familiarity with cGMP, FDA, and ISPE guidelines for pharmaceutical manufacturing.
- Ability to troubleshoot mechanical systems during startup, commissioning, and qualification.
- Proficiency in reviewing and interpreting P&IDs, piping layouts, and engineering specifications.
- Excellent communication and project management skills.
- Experience with large capital projects.
Job Tags
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