Job description
Role Description
Job Description:
This position is the primary site trainer for aseptic behavior, gowning qualification and contamination control as it relates to aseptic manufacture of biologic products and materials. Designs, develops and implements curricula, and conducts training for the Charles City biologics manufacturing site in compliance with site procedures and global standards. Identifies and drives continuous process improvements related to aseptic training. Conducts audits/reviews of personnel to evaluate training effectiveness. Assist with investigations related to aseptic processing. 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:
- Facilitate new employee aseptic training as well as refresher training for site personnel, including gowning qualification and routine process simulations.
- Coordinates required annual training requirements with department management
- Conducts spot checks/audits of aseptic techniques and behaviors during operations
- Observes sterile media fills (SMF) for aseptic practices and best practices.
- Network with the Global Aseptic Team to share best practices.
- Liaison with colleagues to ensure they are trained and understand the criticality of the aseptic process work they are conducting.
- Coordinates personnel training using available technology, including, but not limited to, virtual reality technology.
- Integrates training sessions and training documentation into electronic training document management systems.
- Spend time in the production environment, examining the processes and reviewing the data (example – environmental monitoring). Identify best techniques and practices to help reduce bioburden and contamination.
- Collaborate with area Manufacturing Team Leader to train and lead colleagues in the performance of best aseptic practices.
- Utilize subject matter knowledge related to Aseptic Processing in the conduct of training:
- 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
• Growth and Reproduction
• Sources of Cleanroom Contamination
• Reduction/Elimination
- Measurement Systems
- Site Specific Data Trends and Metrics
- Facility Design / Environmental Controls
Education and Experience:
- BA/BS with 2-4 years of experience OR MBA/MS with 0-2 years of experience related to aseptic manufacturing. 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.
- Familiar/proficient in adult learning methodologies
- 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
Physical Requirements
- Must be able to walk or stand for long periods of time.
- Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
- Must be able to work scheduled 40 hours with the ability to work overtime as needed.
- 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
- Work Environment: While performing the duties of this job, the employee occasionally works in clean room environments. 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.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
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