Engineering Specialist

Engineering Specialist

Position Summary

Catalent Cell and Gene Therapies hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

The Engineering Specialist is responsible for supporting the readiness and reliability strategy for the cell therapy facility at Princeton, NJ site. The Engineer is responsible for contributing to the success of Facilities, Process Equipment and Utility automated and control systems. This position supports the Facilities and Engineering team by providing technical work product. Reports to the Director of Facilities and Engineering.

This is a fulltime, salaried role working 9AM - 6PM; Monday - Friday and occasional weekends as needed.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Candidate

• Responsible for completing assigned work scopes of a project including documentation, compliance commitments, simulation, testing, and commissioning / qualification support.
• Daily responsibilities include SOP development/drafting, implementing performing equipment data back ups/archiving, creating/training end user and assigning access levels and controls for GMP utilities and process equipment.
• Supports CMMS (Blue Mountain RAM) data migration; asset master data creation and induction, determining and establishing events, measurement data templates, and workflows; standardizing equipment list and hierarchy; supporting validation activities.
• Developing and maintaining site SOPs for the CMMS.
• Performs monthly PMs and troubleshooting automation related issues.
• PC hardware and software maintenance for Laboratory and production equipment.
• Technical writing of automation lifecycle documents (Functional Specification, Design Specification, Testing Plans).
• Understanding of process automation needs (e.g. batch reports, Building Temp and RH Trending, Audit Trail reports) for pharma manufacturing.
• This person will be called upon to provide support on projects and engineering maintenance activities.
• Performs other duties as required.

The Role

• A BS in technical field (Electrical, Mechanical, Industrial Engineering), or Associates Degree in a technical field coupled with relevant engineering experience required.
• Minimum 2 years experience in Biotech, Pharmaceutical or Specialty Chemical Industries.

Why You Should Join Catalent

• Competitive salary including 401(k) retirement savings plan with company match
• Medical, dental, vision insurance and Life insurance
• Employee stock purchase plan at discounted rates
• Educational assistance/reimbursement
• 19 days' (152 hours) paid time off, 8 holidays

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 [email protected]. 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 [email protected] for us to investigate with local authorities.

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