Aseptic Processing Specialist

Job Description:

Provide technical expertise for the Charles City aseptic biologics manufacturing site, focused primarily on the Tissue Culture Origin department. Collaborate with Team Leaders and Process Specialist during major investigations including contamination, repeat deviations, and equipment failures. Identify and drive continuous process improvements. Be an active participant on the Global Aseptic Network Team and partner with other sites to ensure CCY is following best practices. Conducts all activities and makes decisions that are in accordance with Company policies & SOPs, Zoetis Values, &global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc.

Position Responsibilities:

• Lead the identification, implementation, and continuous improvement of best practices in aseptic processing within Tissue Culture Origin (TCO). Collaborate with the Global Aseptic Team to exchange knowledge and establish consistent global standards.
• Engage with production environments to observe operations, review relevant data (e.g., environmental monitoring), and proactively identify and implement strategies to reduce bioburden and contamination while increasing process yield.
• Oversee and ensure the effective application of aseptic techniques and procedures across the department in alignment with regulatory and organizational requirements.
• Deliver hands-on training and coaching to colleagues within the aseptic processing area, with a focus on aseptic methodology, environmental monitoring, gowning procedures, and contamination control.
• Champion aseptic and other continuous improvement initiatives and lead the change efforts within the department to drive continuous improvement. Monitor improvements and trends within the department. Supply metrics as needed.
• Collaborate closely with area Team Leaders to train, guide, and develop colleagues in the consistent application of best practices.
• This role is the site expert on all matter related to Aseptic Processing to include the following:
  • Facility Design / Environmental Controls
    * Cleaning and Disinfection (facility surfaces, equipment)
    * Aseptic and Controlled Area Gowning
    * Aseptic Training / Good Aseptic Technique
    * Material Transfer
    * Material/Personnel / Equipment Flow and Movement
    * Use of Isolator and Barrier Systems
    * Sterilization / Validation
    * Bioburden Reduction
  • GMP/Regulatory Requirements
    * Compliance Trends
    *Basic Industrial Microbiology
    * Types of Microorganisms
    * Growth and Reproduction
    * Sources of Cleanroom Contamination
    * Reduction/Elimination
    *Measurement Systems
    * Site Specific Data Trends and Metrics

Education and Experience:

• BA/BS with 2-4 years of experience OR MBA/MS with 0-2 years of experience OR minimum of 8 years relevant experience. Bachelor's degree in Engineering, Biology, Chemistry, Microbiology, Virology, Immunology, or related technical field.
• Must have strong technical/analytical skills and possess a high degree of personal motivation.
• Excellent interpersonal skills and ability to interact across divisional boundaries.

Technical Skills Requirements:

• Must have strong technical/analytical skills and possess a high degree of personal motivation.
• Excellent interpersonal skills and ability to interact across divisional boundaries.
• Strong technical experience specific for this role.
• Strong technical writing skills.
• Preferred experience in biological antigen production systems, biological product formulation (blend/fill/lyophilization), packaging, and/or testing.
• A working knowledge of vaccine production methods and experimental design and experience in GLP or cGMP.
• Knowledge of APHIS, VMD, FDA, USDA regulations applicable to the Pharmaceutical/Biological industry.
• Preferred experience in Lean/Six Sigma. Green Belt certification if currently doesn't have Green belt certification, commitment to obtain green belt certification within 1 year of training.

Physical Requirements:

• Must be able to walk, sit, or stand for long periods of time.
• Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
• Frequent lifting and carrying of 5 to 25 lbs.
• Regular reaching, bending, stooping, and twisting.
• Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
• Able to become qualified to enter clean room environments.
• Other physical demands include: sitting, writing, typing, talking, hearing, seeing, lifting.
• Work Environment: While performing the duties of this job, the employee occasionally works in environments with extreme temperature (hot /cold) & humidity, with limited lighting and in crowded spaces. The noise of these work environments is typical office noise.

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.