Job Information
Yoh Services Mechanical Project Engineer in Philadelphia, Pennsylvania
Reference #: 1168041 Mechanical Project Engineer
Category: Engineering
Employment Type: Contract
Reference: BH-383498-1
We are seeking an experienced Mechanical Project Engineer for a contract assignment to support a Large Pharmaceutical Capital project!
Duration: One year contract assignment, possibility of extension Location: Philadelphia, PA (onsite) Work Schedule: Fulltime, M-F. Pay Rate: $60 - $80/hour, based on experience
SUMMARY 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. 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. Will work within the Engineering department and directly with Facilities, Manufacturing Operations, Validation and Metrology. This person will also routinely work with and support project startup, construction, and applicable subcontractors.
RESPONSIBILTIES Engineering Design & Execution
Oversee the 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, including clean and dirty utilities. Review and approve engineering submittals from vendors and contractors to ensure alignment with project specifications and approved Engineering design. Review mechanical drawings, P&IDs, and specifications, identifying discrepancies and providing resolutions. Respond to Requests for Information (RFIs), ensuring clarity and accuracy in engineering documentation. Support detailed design reviews and risk assessments and ensure all mechanical systems meet GMP, FDA, and other standards. Vendor & Stakeholder Management
Manage relationships with equipment vendors, construction management, 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 teams. Participate in and coordinate Site Acceptance Testing (SAT) for critical mechanical equipment, as applicable. Project Coordination & Instrument Implementation
Oversee the planning, day to day coordination / execution, and completion of mechanical system implementation in alignment with the broader capital project timeline. Develop and maintain project schedules, ensuring timely delivery, installation, commissioning, and qualification of Mechanical system. Collaborate with internal stakeholders, including Quality, Validation, Procurement, Facilities and Metrology teams to ensure smooth project execution. Startup, Commissioning & Qualification
Support the development and execution of startup and commissioning plans for mechanical systems, including utilities, autoclaves, and parts washers. Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities as applicable. Ensure all commissioning and qualification activities adhere to cGMP, FDA, and our Quality policies and procedures. Participate in and facilitate punch list generation, review, and resolution of outstanding issues before system handover.
Project Support & Problem-Solving
Provide technical troubleshooting and resolution for mechanical system challenges during startup and commissioning. Identify and mitigate risks related to mechanical system performance, compliance, and reliability. Ensure proper documentation of all engineering activities, including change control and validation protocols. Compliance, Documentation & Reporting
Ensure all installations and qualifications are completed in accordance with FDA, USP, ICH, and other applicable regulatory standards. Maintain detailed records of project progress, vendor interactions, qualification protocols, deviations, and corrective actions. Assist in the development and revision of Standard Operating Procedures (SOPs) related to equipment / system operation, maintenance, and qualification. Provide regular status updates to project teams and leadership, highlighting risks, challenges, and mitigation strategies. QUALIFICATIONS
BS degree required and Professional Engineering (PE) license or advanced degree in Mechanical Engineering preferred. Minimum of 7 years of experience in mechanical engineering within (GMP) pharmaceutical or biotech industry. Must have project management experience with large capital projects ($50M+ budget) and ability to manage multiple priorities and timelines. Must be knowledgeable in cGMP, FDA, and ISPE guidelines related to pharmaceutical manufacturing. Excellent organizational, problem-solving, and multitasking abilities. Exceptional communication and interpersonal skills to effectively liaise with internal teams and external vendors. Knowledge of 3D modeling software (AutoCAD, Revit) and project management tools. Extensive knowledge of clean and dirty utilities in a GMP environment. Ability to troubleshoot mechanical systems during startup, commissioning and qualification. Strong background in engineering reviews, commissioning, qualification, and validation of mechanical systems. Knowledge of 3D modeling software (AutoCAD, Revit) and project management tools. ESTIMATED MIN RATE: $70.00 ESTIMATED MAX RATE: $80.00
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Yoh, a Day & Zimm