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Engineer

Engineer

ZoetisKalamazoo, MI, United States
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States considered : Michigan

Role Description

The Injectable Manufacturing Engineer will work within the Aseptic and Terminally Sterilized Value Streams to support manufacturing and validation / qualificationoperations.

As well, the Engineer will be responsible for leading technical programs and implementation activities to improve manufacturing processes and maximize the maintenance related uptime and operating efficiencies. These activities help minimize costs and contribute to the profitability and performance of the business.

The ideal candidate will also work in cross-functional teams to identify and implement safety, quality, efficiency and cost improvements (CIP's) on equipment and processes within operations.

Responsibilities will include :

  • Act as a subject matter expert for sterilization systems.
  • Support daily operations activities. This includes troubleshooting, investigating root cause of deviations, implementing corrective / preventative actions, and implementing process improvements.
  • Temporarily assist with 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.
  • Lead, execute and deliver annual Continuous Improvement Projects Lead and author deviation investigations to identify root causes and implement corrective actions.
  • Execute qualification / validations / line trials to support projects, including the authoring of change control documents.
  • Perform initial qualification of new sterilization systems.
  • Assist with the authoring of batch records, protocols and SOPs.
  • Periodic review and / or routine troubleshooting of 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.
  • Provide project management of technical projects to deliver projects on time and to budget.
  • Communicates changes and updates to stakeholders.
  • Facility support may be required during non-routine hours.
  • Travel to equipment manufacturers and contract sterilizers will be required.
  • Promotes the use of Reliability Engineering concepts and tools to the Engineering and Production departments.
  • Establishes guidelines and specifications (i.e. : Task, Frequency, Materials, Skill, Calibration parameters, etc.) for properly implementing equipment Preventive Maintenance and equipment health activities.
  • Performs reliability analysis (FRACAS, FMEA) to identify root causes of equipment issues.
  • Identifies chronic equipment deficiencies through "Bad Actor" analysis.
  • Develops procedures and specifications for the reliability maintenance aspects for existing and new equipment.

REQUIRED QUALIFICATIONS

  • BS in Biology, Microbiology, Chemistry, or Engineering / related field or 3+ years of related experience and MS Biology, Microbiology, Chemistry, or Engineering / related field
  • Basic knowledge of microbiology
  • Basic understanding of statistical analysis
  • Basic understanding of manufacturing equipment. Experience within a pharmaceutical environment preferred.
  • Language Skills : Technical Writing required, along with effective written and oral communication
  • Computer Skills : Microsoft Applications, Minitab or comparable statistical software
  • DESIRED QUALIFICATIONS

  • 5+ years of related experience
  • Experience in lean six sigma, value stream mapping, visual management, 5S, etc.
  • Experience in injectable manufacturing (aseptic and / or terminal sterilization)
  • Prior clean room / aseptic area gowning certification or understanding of qualifications
  • Experience with sterilization system qualification
  • Full time Regular Colleague

    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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