Mechanical Engineer - 153669

Atrium; Philadelphia (Philadelphia County); On-site; USD 60,000 - 80,000; Full time

Job summary

An innovative pharmaceutical company is seeking a skilled Mechanical Engineer to lead engineering design and project execution. This role is pivotal in supporting large capital projects, ensuring compliance with stringent GMP regulations, and delivering high-quality mechanical systems. The ideal candidate will possess strong problem-solving abilities and excellent communication skills, thriving in a collaborative environment. Join a forward-thinking team that values diversity and offers an inclusive workplace where your contributions will be recognized and celebrated. This is an exciting opportunity to make a significant impact in the lives of patients through cutting-edge research and development.

Benefits

Healthcare plans

Discount programs

Paid time off

Qualifications

• 4-5+ years of experience in mechanical engineering in a regulated industry.
• In-depth knowledge of clean and dirty utilities in GMP environments.

Responsibilities

• Lead mechanical engineering aspects of projects ensuring compliance with GMP regulations.
• Provide technical expertise in designing and integrating mechanical systems.

Skills

Mechanical Engineering

Problem-Solving

Project Management

Communication Skills

Regulatory Compliance (GMP, FDA)

Education

Professional Engineering (PE) license

Advanced degree in Mechanical Engineering

Tools

AutoCAD

Revit

Job description

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
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. Parking is not provided, but the company is very accessible on public transportation. The team is excited to welcome a Mechanical Engineer.

Salary/Hourly Rate
$50/hr - $65/hr

Position Description
The Mechanical Engineer will support large pharmaceutical capital projects and will be responsible for engineering design, procurement, startup, vendor coordination, commissioning, and qualification. The Mechanical Engineer will have great interpersonal and communication skills and will be a self-starter.

Responsibilities Of The Mechanical Engineer

• Lead 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:

• The role 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:

• Professional Engineering (PE) license or an advanced degree in Mechanical Engineering.

Benefits:

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

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.

EOE/M/F/D/V/SO

Position ID: 153669

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Engineering and Information Technology

Industries

Staffing and Recruiting