Mechanical Engineer/Project Manager

About Atrium:

What you do matters. As a people-centric organization, we foster an environment of collaboration, high performance, and innovation where your talents are valued, and your achievements are celebrated. Join us and become part of an inclusive team.

Client Overview:

Our client is an innovative and growing pharmaceutical company that is on the cutting edge of new research aimed at making major changes in the lives of patients. This is a large company with multiple locations, highly regulated laboratories and state of the art equipment. Currently, they are looking to add a Mechanical Engineer/Project Manager to their team.

Salary/Hourly Rate:

$70/hr – $85/hr

Position Overview:

The Mechanical Engineer/Project Manager will support large pharmaceutical capital projects and will be responsible for engineering design, procurement, startup, vendor coordination, commissioning, and qualification. The Mechanical Engineer/Project Manager will have great interpersonal and communication skills and will be a self-starter. Parking is not provided, but the company is very accessible by public transportation.

Responsibilities of the Mechanical Engineer/Project Manager:

• The Mechanical Engineer/Project Manager will lead the mechanical engineering aspects of the project, ensuring compliance with GMP regulations and industry standards.
• Provide technical expertise in designing and integrating mechanical systems, including clean and dirty utilities, autoclaves, and parts washers.
• Review and approve engineering submittals from vendors and contractors to ensure they align with project specifications and approved designs.
• Analyze mechanical drawings, P&IDs, and specifications, identifying discrepancies and proposing resolutions.
• Respond to RFIs, ensuring clarity and accuracy in engineering documentation.
• Support detailed design reviews and risk assessments to ensure all mechanical systems meet GMP, FDA, and company standards.
• Coordinate with equipment vendors, contractors, construction management teams, and suppliers, ensuring timely delivery and compliance with project requirements.
• Review and validate vendor submittals, including material certifications, technical data sheets, and performance guarantees.
• Assist in the development and execution of startup and commissioning plans for mechanical systems, including utilities, autoclaves, and parts washers.
• Provide technical troubleshooting and resolution for mechanical system challenges during startup and commissioning.
• Ensure all installations and qualifications adhere to FDA, USP, ICH, and other applicable regulatory standards.
• Manage the planning, coordination, and execution of mechanical system implementation, ensuring alignment with the broader capital project timeline.

Required Experience/Skills for the Mechanical Engineer/Project Manager:

• The Mechanical Engineer/Project Manager needs 4 – 5 years+ of experience as a Mechanical Engineer in a regulated industry like pharmaceuticals, biotechnology, medical device, personal care, consumer goods or chemicals.
• In-depth knowledge of clean and dirty utilities, autoclaves, and parts washers in a GMP-regulated environment.
• Experience with engineering reviews, commissioning, qualification, and validation of mechanical systems.
• Proficiency in managing RFIs, vendor submittals, engineering drawings, and turnover documentation.
• Familiarity with cGMP, FDA, and ISPE guidelines for pharmaceutical manufacturing.
• Excellent problem-solving skills with the ability to troubleshoot mechanical systems during startup, commissioning, and qualification.
• Ability to review and interpret P&IDs, piping layouts, and engineering specifications/records.
• Strong communication and project management skills, with the ability to coordinate across engineering, commissioning, quality, and construction teams.
• Experience executing large capital projects.
• Experience with AutoCAD and Revit.

Education Requirements:

• An Engineering (PE) license or an advanced degree in Mechanical Engineering is required.

Benefits:

• Atrium Care Package available, upon eligibility (including healthcare plans, discount programs, and paid time off).

By applying to this job, you agree to receive calls, AI-generated calls, text messages, and/or emails from Atrium and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to opt out on any message you receive. For more details, please review our Terms of Use and Privacy Policy.

As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.
EOE/M/F/D/V/SO