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.

This position will work under Spark Therapeutics’ Site Engineering teams and directly with Facilities, Manufacturing Operations, Validation and Metrology.This person will also routinely work with and support project startup, construction, and applicable subcontractors.

Responsibilities

Engineering Design & Execution

1. Oversee the Mechanical Engineering aspects of the project, ensuring compliance with GMP regulations and industry best practices.
2. Provide technical expertise in the design and integration of mechanical systems, including clean and dirty utilities, autoclaves, and parts washers.
3. Review and approve engineering submittals from vendors and contractors to ensure alignment with project specifications and approved Engineering design.
4. Review mechanical drawings, P&IDs, and specifications, identifying discrepancies and providing resolutions.
5. Respond to Requests for Information (RFIs), ensuring clarity and accuracy in engineering documentation.
6. Support detailed design reviews and risk assessments and ensure all mechanical systems meet GMP, FDA, and Spark Therapeutics’ standards.

Vendor & Stakeholder Management:

1. Manage relationships with equipment vendors, construction management, contractors, and suppliers, ensuring timely delivery and compliance with project requirements.
2. Review and validate vendor submittals, including material certifications, technical data sheets, and performance guarantees.
3. Collaborate with cross-functional teams, including process engineers, operations, facilities, quality, validation, and construction teams.
4. Participate in and coordinate Site Acceptance Testing (SAT) for critical mechanical equipment, as applicable.

Project Coordination & Instrument Implementation:

1. Oversee the planning, day to day coordination / execution, and completion of mechanical system implementation in alignment with the broader capital project timeline.
2. Develop and maintain project schedules, ensuring timely delivery, installation, commissioning, and qualification of Mechanical system.
3. Collaborate with internal stakeholders, including Quality, Validation, Procurement, Facilities and Metrology teams to ensure smooth project execution.

Startup, Commissioning & Qualification:

1. Support the development and execution of startup and commissioning plans for mechanical systems, including utilities, autoclaves, and parts washers.
2. Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities as applicable.
3. Ensure all commissioning and qualification activities adhere to cGMP, FDA, and Spark Therapeutics’ Quality policies and procedures.
4. Participate in and facilitate punch list generation, review, and resolution of outstanding issues before system handover.

Project Support & Problem-Solving:

1. Provide technical troubleshooting and resolution for mechanical system challenges during startup and commissioning.
2. Identify and mitigate risks related to mechanical system performance, compliance, and reliability.
3. Ensure proper documentation of all engineering activities, including change control and validation protocols.

Compliance, Documentation & Reporting:

1. Ensure all installations and qualifications are completed in accordance with FDA, USP, ICH, and other applicable regulatory standards.
2. Maintain detailed records of project progress, vendor interactions, qualification protocols, deviations, and corrective actions.
3. Assist in the development and revision of Standard Operating Procedures (SOPs) related to equipment / system operation, maintenance, and qualification.
4. Provide regular status updates to project teams and leadership, highlighting risks, challenges, and mitigation strategies.

Education and Experience Requirements

1. Minimum 7 years of experience in mechanical engineering within the pharmaceutical or biotech industry.
2. Extensive knowledge of clean and dirty utilities, autoclaves, and parts washers in a GMP environment.
3. Strong background in engineering reviews, commissioning, qualification, and validation of mechanical systems.
4. Experience managing RFIs, vendor submittals, engineering drawings, and turnover documentation.
5. Familiarity with cGMP, FDA, and ISPE guidelines related to pharmaceutical manufacturing.
6. Excellent problem-solving skills with the ability to troubleshoot mechanical systems during startup, commissioning and qualification.
7. Proficiency in reviewing and interpreting P&IDs, piping layouts, and engineering specifications/records.
8. Strong communication and project management skills with the ability to coordinate between engineering, commissioning, quality, and construction teams.
9. Experience with Large Capital Project Execution
10. Strong attention to detail and problem solving skills.
11. Ability to work independently and cross-communicate.

Preferred

1. Professional Engineering (PE) license or advanced degree in Mechanical Engineering.
2. Experience with large capital projects ($50M+ budget) in a regulated environment.
3. Knowledge of 3D modeling software (AutoCAD, Revit) and project management tools.

Compensation:

$80-160K

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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