Engineering Technician

Catalent; Harmans (MD); On-site; USD 46,000 - 56,000; Full time

Benefits offered by this job

Annual bonus

401K match

Paid time off

Medical, dental & vision benefits

Tuition Reimbursement

Job summary

Catalent is seeking an Engineering Technician to provide technical support for GMP manufacturing and testing operations at the Harmans, MD facility. You will maintain equipment reliability, perform preventive maintenance, and troubleshoot a range of bioprocess equipment in a 100% onsite environment.

The role requires 3+ years in GMP/Bio-Pharma maintenance, the ability to work in cleanrooms with full gowning, and strong repair/maintenance skills.

Qualifications

• High School Diploma required; Associate or Bachelor’s degree preferred.
• Minimum 3 years of GMP/Bio-Pharma maintenance/engineering experience.
• Ability to lift/carry 40 lbs and work on ladders/step stools.
• Clear verbal and written communication skills.

Responsibilities

• Analyze and develop engineering solutions for maintenance, improvement, quality and safety initiatives.
• Troubleshoot and repair bioprocess equipment.
• Generate and update PM SOPs/records and maintain equipment history files.
• Use CMMS to complete preventive and responsive maintenance work orders.
• Collaborate with vendors and Catalent purchasing on parts and instrumentation.
• Work in cleanrooms with full gowning requirements.

Skills

Mechanical repairs

Electrical repairs

Troubleshooting

Communication

Education

Associate/Bachelor's degree preferred

Tools

CMMS

Job description

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.

Engineering Technician

Position Summary: The Engineering Technician provides technical support for GMP manufacturing and testing operations 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 Thursday - Saturday and every other Wednesday

Location: Harmans, MD - BWI

100% Onsite

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.

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 3 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 $33.65 - $40.86 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.

Why You Should Join Catalent

• 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

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 [e-mail]. 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 [e-mail] for us to investigate with local authorities.

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