Lead Technician - Process Engineering

The Lead Technician – Process Engineering will provide technical support to GMP manufacturing/testing operations for Phase I/II bulk, Phase III and finished biologics in our multi-product facility in Harmans, MD. The Lead Technician- Process Engineering will report to the Manager – Process Engineering and will be responsible for the overall facilities including executing the preventative maintenance, repairs, and installation of process equipment.

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 Role

• Analyze and develop engineering solutions to maintenance, continuous improvement, quality and safety initiatives, and failure investigations for manufacturing equipment/systems and instrumentation.
• Work independently on assigned projects and collaboratively in a multi-functional team environment supporting day-to-day manufacturing schedules and operations.
• Drawing upon seasoned mechanical and electrical experience, will engage in hands-on work troubleshooting and lead the repairing of bioprocess equipment. Equipment includes fermenters, bioreactors, centrifuges, chromatography systems, incubators, BSCs, controlled temperature units, and laboratory equipment.
• Work within Computerized Maintenance Management Systems (CMMS) to complete preventive and responsive maintenance work orders.
• Work within manual and electronic Facilities Engineering documentation systems to maintain engineering drawings and equipment history files.
• Work with subcontractors as needed on equipment preventive maintenance, calibrations, and repairs.
• Assist in maintaining PM programs for the bioprocess equipment and instrumentation. This includes generating PM SOPs/records, establishing PM frequencies, specifying spare parts and recommending/maintaining inventory levels.
• Work with equipment vendors and Catalent’s purchasing department to quote/purchase/procure equipment parts and instrumentation.
• Assist in training of mechanics and manufacturing personnel on the various pieces of bioprocess equipment throughout the facility.
• Develop job aids, work instructions, and troubleshooting guides for performing of routine maintenance and repairs. Will be responsible for generating and updating documentation throughout the life cycle of the equipment.
• Work in cleanrooms that requires full gowning (tyvek coverall, gloves, hair cover, shoe covers.)
• Work extended periods on his/her feet in a manufacturing environment.
• Shift work and/or weekend work will be required at times.
• Must follow all Catalent’s Safety and Quality procedures and practices.

The Candidate

• High School Diploma required; Associates/Bachelors degree preferred
• 5 years or more years related work experience (GMP / Bio-Pharma maintenance/ engineering); clean room experience or experience in a similarly regulated industry.
• Must demonstrate abilities in mechanical/electrical repairs and maintenance.
• Automation and controls operation, repairs and maintenance are preferred.
• Requires basic math and computer skills (eg. Word and Excel)
• Must have the ability to lift/carry 40 lbs. and to work on ladders/step stools.
• Requires working extended periods on his/her feet in a fast-paced environment.

Catalent Benefits

• Potential for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross functional exposure to other areas of within the organization
• Medical, Dental, Vision, and 401K are all offered from day one of employment
• 19 days of paid time off annually + 8 paid 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 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.