Technician II, Central Services

Catalent Pharma Solutions; Glen Burnie (MD); On-site; USD 33,000 - 40,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Tuition Reimbursement

Job summary

Catalent Pharma Solutions is seeking a Technician II, Central Services in Harmans, MD. The role supports manufacturing by applying broad scientific principles to operations in central services, contributing to bulk biologics production for Phase I/II and commercial GMP manufacturing.

Shift: Day 7am-7pm, 2-2-3 rotation, 100% onsite. The candidate will manage batch records, SOPs, deviations, CAPAs, and collaboration with Process Development and MS&T to implement new GMP processes, while

Qualifications

• High School diploma or GED with 2-4 years of GMP-compliant upstream or downstream biologic production experience preferred
• Associate degree with 2-4 years GMP experience preferred
• Bachelor’s degree with 1-3 years GMP experience preferred

Responsibilities

• Complete and maintain Batch Production Records and GMP documentation
• Author, revise, and manage SOPs, batch records, protocols, deviations, CAPAs, and reports
• Support tech transfer with Process Development and MS&T teams to introduce new GMP processes
• Initiate, investigate, and close deviations and CAPAs; lead RCA investigations
• Troubleshoot manufacturing processes and equipment with Facilities, Engineering, Validation
• Collaborate with production leadership to develop and implement processes meeting timelines
• Recommend and support procurement of equipment and supplies to improve efficiency
• Participate in facility expansion, equipment qualification, validation, and continuous improvement
• Perform and oversee cleaning and maintenance of manufacturing equipment and controlled environments
• Collaborate with internal and external clients during campaigns, providing technical support
• Perform other duties as assigned

Skills

Upstream/bioreactor

Downstream/chromatography

Documentation skills

GMP knowledge

Education

High School diploma/GED

Associate degree in Scientific/Engineering/Biotech

Bachelor’s degree in Scientific/Engineering/Biotech

Tools

Microsoft Office

Job description

Technician II, Central Services

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

We have an opportunity for a Technician II, Central Services to join our team. In this role, you will support manufacturing processes in Central Services by applying broad knowledge of theories and principles to solve operational and routine tasks. You will contribute to the production of bulk biologics from microbial and cell culture systems for Phase I/II and commercial GMP manufacturing. This position reports to the Central Services Supervisor assigned to the shift. Shift work and weekend work may be required at times.

Shift: Day shift 7am-7pm on a 2-2-3 rotation
Location: Harmans, MD - BWI
100% Onsite

The Role

• Complete and maintain Batch Production Records and GMP documentation in compliance with SOPs, regulatory requirements, and data integrity standards.
• Author, revise, and manage manufacturing documentation, including SOPs, batch records, protocols, deviations, CAPAs, and summary reports.
• Support technology transfer activities by partnering with Process Development and MS&T teams to introduce new processes into GMP manufacturing.
• Initiate, investigate, and close deviations and CAPAs, including leading root cause investigations and implementing corrective actions.
• Troubleshoot manufacturing processes and equipment issues while coordinating with Facilities, Engineering, and Validation teams to ensure operational readiness.
• Collaborate with production leadership to develop, optimize, and implement manufacturing processes that meet operational objectives and timelines.
• Recommend and support procurement of manufacturing equipment, supplies, and resources to enhance production efficiency.
• Participate in facility expansion, equipment qualification, validation, and continuous improvement initiatives.
• Perform and oversee cleaning and maintenance activities for manufacturing equipment and controlled production environments.
• Partner cross-functionally with internal teams and external clients during manufacturing campaigns, providing technical support, project coordination, and operational expertise.
• Perform other duties as assigned

The Candidate

Minimum Requirements

• High School diploma or GED with 2-4 years of experience in upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance preferred
• Associate degree in a Scientific, Engineering, or Biotech field with 2-4 years of experience in upstream or downstream biologic production processes under GMP compliance preferred
• Bachelor’s degree in a Scientific, Engineering, or Biotech field with 1-3 years of experience in upstream or downstream biologic production processes under GMP compliance preferred
• Strong knowledge and ability to apply scientific principles to solve operational and routine production tasks
• Excellent documentation skills including comprehension, review, and establishing Batch Production Records, Standard Operating Procedures, deviations, and summary reports
• Thorough knowledge of current Good Manufacturing Practices and relevant safety procedures; general understanding of most areas in Manufacturing and supporting functional groups
• Strong team player with excellent written and verbal communication skills, able to build and maintain effective cross-functional relationships across departments and support functions.
• Flexible, adaptable, and self-motivated professional with basic knowledge of Quality Control, Quality Assurance, Regulatory, and Materials Management, as well as proficiency with Microsoft Office and the ability to work independently or collaboratively.
• Ability to perform physical job requirements, including extended periods of standing, walking, and bending, lifting up to 25 lbs, and wearing a Powered Air Purifying Respirator (PAPR) when handling certain chemicals.

Preferred Skills & Background

• Experience with Media and/or Buffer Preparation

Pay

The anticipated hourly rate for this position in MD is $24.03 – $28.84 Plus Bonus. 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
• Competitive paid time off plus 8 paid holidays
• Community engagement and green initiatives
• Medical, dental, and vision benefits effective day one of employment
• Tuition Reimbursement

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.

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.

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Volunteer Work Disclosure:

Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.