Mechanical Engineer

Position Summary:

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

The Facilities Department is responsible for all facilities operations, maintenance, and calibration of direct and indirect equipment to the manufacturing process, and project management for expansions or remodeling. This department manages facilities planning, construction, and renovation, including primary contact and management of architects, design engineers, contractors, and subcontractors. The Facilities Department is also responsible for managing the facility in a manner that assures uninterrupted cGMP compliance in existing manufacturing areas, as well as the research and process development areas.

This is a full- time, salaried, position: Monday – Friday, 8:00 am – 5:00 pm.

The Engineer will support ongoing Facilities activities by assisting in troubleshooting mechanical problems, identifying improvements in utilities to minimize interruptions (down time) and reduce energy usage/cost, and supporting new and ongoing projects. The Engineer will further assist in the management and planning of project budgets and schedules and provide contractor oversight. This position will assist in identifying, tracking, forecasting, and implementing capital expenditure projects by working with site leadership and departmental end users to identify the correct project parameters and utility requirements. The Engineer may establish new Standard Operating Procedures (SOPs) and/or recommend changes to current SOPs based on facility needs.

The Role:

• Support the multi-use facility, including HVAC systems and bio-containment systems
• Support selection and installation of manufacturing equipment
• Proactively and effectively partner with the facility commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirements
• Draft SOPs for building operation, maintenance, and calibration
• Identify improvements and efficiencies of facility preventative maintenance
• Provide engineering guidance and execution on facilities and equipment projects
• Perform hands-on activities as needed to help troubleshoot facility problems and support facility staff
• Develop standard processes to evaluate future capital projects
• Create and maintain all aspects of equipment design files
• Guide the specification and selection of manufacturing/utility equipment to support site facility/ process needs
• Author deviation investigation and change control process
• Other duties as assigned

The Candidate:

• Minimum Bachelor of Science degree with concentrated studies in Engineering or Science.
• Minimum 3 years facilities operation/engineering experience in a cGMP environment (preferable biopharmaceutical).
• Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions.
• Ability to complete investigation, deviation, and change control forms independently.
• Write, edit, review SOPs
• Exposure to contractual management and processes.
• Problem-solving (Lean six sigma) and change management methodologies consistent with establishing a culture of continuous improvement is preferred.
• Must comply with EHS responsibilities for the position.

Catalent Benefits:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of paid time off annually + 8 paid holidays
• Competitive salary with yearly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement
• On-site fitness center and wellness programs

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.