From Catalent Pharma Solutions's posting. “We” and “our” refer to the employer.
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.
Visit Catalent Careers to explore career opportunities.
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.
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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.
Massachusetts Lie Detector Test Notice: 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.
Employer application notice
Equal opportunity and accommodations
Catalent is an Equal Opportunity Employer, including disability and veterans.
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