POSITION SUMMARY
The Injectable Mfg. Validation and Product Support Engineer will work within the Aseptic and Terminally Sterilized Value Streams to support manufacturing and validation/qualification operations. The ideal candidate will also work in cross-functional teams to identify and implement efficiency, safety, quality and/or cost improvements (CIP s) on equipment and processes within the injectable manufacturing operations.
Responsibilities will include:
* Annual/periodic requalification of established sterilization systems including but not limited to autoclave, batch and continuous dry-heat depyrogenation, steam-in-place (including vent filters and freeze dryer),gamma/e-beam irradiation, VDmax dose audits, and sterility testing isolators.
* Initial qualification of new sterilization systems.
* Periodic review and/or routine troubleshooting of sterilization system failures or deviations, including root-cause analysis and corrective/preventative action implementation.
* Provide support for microbiological and/or validation assessments/evaluations, including using Quality Risk Management tools.
* Execute validations/line trials to support projects, including the authoring of change control documents.
* Assist the QC Microbiology department with environmental/personnel monitoring investigations in classified areas.
* Assist the Aseptic Value Stream Mfg. Product Support Engineer with tasks related to root-cause analysis for aseptic formulation, filling, and freeze dry process deviations.
* Technical writing skills are required.
* Facility support may be required during non-routine hours.
* Travel to contract sterilizers will be required.
EDUCATION AND EXPERIENCE
* 5+ years of related experience and BS in Biology, Microbiology, Chemistry, or Engineering / related field or 3+ years of related experience and MS Biology, Microbiology, Chemistry, or Engineering / related field
* Experience in injectable manufacturing (aseptic and/or terminal sterilization) is required. Experience with sterilization system qualification is preferred.
* Basic knowledge of microbiology is preferred.
* Leadership: knowledgeable of basic leadership principles
* Language Skills: Effective written and oral communication
* Computer Skills: Microsoft Applications
* Work Environment: Office environment, with frequent time on the manufacturing floor. Use of hearing and eye protection is required. Clean room and aseptic area gowning is required when working in GMP manufacturing environments.
* Lean six sigma experience is preferred
Full time
Regular
Colleague
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 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.
Employer's Job# JR00003190
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