Senior Engineering Technician

Catalent • Harmans, MD

12d • $38 - $43 • Onsite

About The Position

Catalent is a leading global CDMO partnering with pharma and biotech innovators to accelerate development and delivery of life-changing therapies. Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MD—just minutes from BWI Airport—features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through commercial production of advanced therapies, including AAV and other viral vector-based products. We are currently seeking a Senior Engineering Technician to 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 Senior Engineering Technician will be responsible for the overall facilities including executing the preventative maintenance, repairs, and installation of process equipment.

Requirements

• 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.
• 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.

Nice To Haves

• Automation and controls operation, repairs and maintenance are preferred.

Responsibilities

• 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.
• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree