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Severn, Maryland, United States
Onsite
Senior Engineering Technician
About Site
Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.
The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.
The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.
Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.
Position Summary:
The Senior Engineering Technician will be responsible for the overall facilities including executing the preventative maintenance, repairs, and installation of process equipment supporting Phase I/II bulk production, Phase III clinical manufacturing, and commercial biologics within a multi-product facility. This role is responsible for maintaining facility and process equipment reliability through the execution of preventive maintenance programs, troubleshooting and repairs, and installation of manufacturing equipment. The Engineering Technician works closely with cross-functional teams to ensure equipment performance, operational efficiency, and compliance with GMP requirements, and reports directly to the Supervisor, Engineering Technician.
Shift: Day Shift - 6am-6pm Sunday - Tuesday and every other Wednesday
Location: Harmans, MD - BWI
100% Onsite
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.
Will engage in hands-on work troubleshooting and lead the repairing of bioprocess equipment. Equipment includes fermenters, bioreactors, centrifuges, tangential flow filtration systems, 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 engineering documentation systems to maintain engineering drawings and equipment history files.
Work with subcontractors and vendors 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.
Develop job aids, work instructions, and troubleshooting guides for performing 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.)
Other duties as assigned
The Candidate:
High School Diploma required; Associates/Bachelors degree preferred.
A minimum of 5 years of related work experience, specifically in GMP / Bio-Pharma maintenance and/or engineering experience; Clean room experience or experience in a similar GMP / FDA 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) and must be able to clearly communicate (verbal, written).
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 manufacturing environment and must follow all Catalent’s Safety and Quality procedures and practices.
The anticipated hourly rate for this position in Maryland is $38.46 - $52.88 plus shift differential and annual bonus, when eligible. The final hourly rate offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
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.
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.
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