Associate I, Manufacturing - Fill Finish

Manufacturing Associate I, Fill Finish

2nd shift)

Position Summary :

Catalent Cell and Gene Therapy is looking to recruit a Manufacturing Associate I, Fill Finish to join our growing team in Harmans, MD.

The Manufacturing Associate I, Fill Finish is responsible for conducting daily production activities in accordance with Good Manufacturing Practices (GMP).

Accountable for final formulation and filling for the manufacture of biopharmaceutical products under cGMP. Performs media simulation runs of processes as needed to ensure they are appropriately aseptic.

This role is on 2nd shift, Monday Friday 2 : 00 pm - 10 : 30 pm.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role

• Performs Processing Steps and / or Manufacturing Support activities, monitoring process against the batch record.
• Complete and review GMP documentation and production records for accuracy and make corrections promptly.
• Assist in all areas of GMP clinical and commercial fill / finish activities. Includes, but is not limited to automated and semi-automated vial filling operations, vial inspection, vial labeling, media and associate qualification activities, etc.
• Demonstrates working knowledge of formulation and filling equipment, including maintenance issues. Understands validation issues and supports validation activities as they pertain to the equipment and processes.
• Demonstrates knowledge of final formulation and filling techniques, materials and equipment.
• Prepare reagents, buffers, and equipment for processing
• Operate automated and semi-automated fill / finish equipment, environmental monitoring equipment, and basic GMP processing equipment.
• Support aseptic filling and packaging process for bio products and use automated filling equipment in an aseptic manufacturing environment
• Adhere to Quality standards and learn and comply with regulatory requirements.
• Documents / Records cGMP data and information for processing steps and / or equipment activities, following standard operating procedures.

Key documentation includes batch records and equipment logbooks.

Perform other duties as assigned.

The Candidate :

• HS or GED with a minimum of 4 years’ experience in cGMP regulated environment, OR
• Associate degree in a Scientific, Engineering or Biotech field with a minimum 2 years’ experience in cGMP regulated environment, OR
• Bachelor’s degree in a Scientific, Engineering or Biotech field with a minimum 0+ years’ experience in a cGMP-regulated environment.
• Aseptic / sterile manufacturing experience preferred.
• Working knowledge of documentation including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports preferred.
• Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).
• Understand routine procedures upon which they have been trained.
• Possesses a basic understanding of equipment function and applications. Proficient in MS Office and related PC skills.

JOB REQUIREMENTS :

• Lifting to 40 lbs., unassisted may be required at times.
• Shift work, overtime, and / or weekend work is required at times.
• Standing for extended periods of time with full sterile gowning and goggles within the aseptic cleanroom.
• Ability to perform aseptic gowning procedures.

Why you should join Catalent :

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Defined career path and annual performance review & feedback process
• Cross-functional exposure to other areas within the organization
• Medical, Dental, Vision, and 401K are all offered from day one of employment
• 152 hors of PTO and 8 paid holidays
• 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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety.

The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

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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 .

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 for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice .