Process Verification Specialist mAbs at Zoetis in Lincoln, Nebraska

Posted in Other about 3 hours ago.





Job Description:

States considered:



Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals.




At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in the Lincoln community. We are a clean, modern site that continues to innovate and grow.




Benefits Include:



$500 Sign on Bonus


4 weeks accrued paid vacation and 13 paid holidays.


401(k) match with company profit sharing.


Tuition reimbursement and Student Loan repayment program.


Great Health, personal, and family benefits starting day 1.



Position Summary



The candidate will be responsible for supporting various activities within mAb operations not limited to closing of process in SAP, GMP review of the batch records, audit of the batch records, CAPA and change management. Understand, follow, and complete process documentation in support of GMP. Understand and follow safety policies as it relates to biological and chemical components and equipment to protect personnel and maintain product quality. This position will report directly to the manufacturing team, presence on the manufacturing floor expected.



Hours: 1st shift, Monday - Friday 7:00am - 6:00pm (40 hrs/week) occasional rotating weekends.




Position Responsibilities



  • Responsible for the production batch record GMP review and 100% right first-time goal achievement.

  • Assist with batch record data assembly.

  • Responsible for deviation pareto board update and assist with deviation trending.

  • Assist with deviation investigation and write-up (manufacturing and environmental investigations) and change management.

  • Responsible for related manufacturing CAPA implementation

  • Participate in daily manufacturing/Quality assurance meeting.

  • Train colleagues on GMP documentation and ensure team compliance during execution and throughout review of the batch records.

  • Act as a liaison and collaborate with manufacturing support groups (quality assurance and mAb technical support) to ensure respect of GMP practice and appropriate CAPA defined.

  • Understand, follow, and complete process documentation in support of GMP.

  • Understand and follow safety policies as it relates to biological and chemical components and equipment to protect personnel and maintain product quality.

  • Participate in mAbs production process activities at least 30% of the work week.




Education and Experience



BS in Biological sciences, Biochemistry, Biotechnology or related field, MA/MS preferred. Preference given to applicants with relevant experience in mAb production. Candidate with high school diploma and relevant experience may be considered.



Technical Skills and Competencies Required




Functional skills:


  • Ability to read and follow written directions.

  • Ability to communicate effectively both verbally and in writing.

  • Ability to coach/train colleagues

  • Ability to think critically.

  • Ability to function independently when required.


Technical skills:



  • Basic computer skills (Word and Excel)

  • Proficiency in SAP

  • Ability to troubleshoot.

  • Proficiency in Delta V

  • Knowledge in GMP environment


Desirable skills:



  • Familiarity with biologic manufacturing process

  • Knowledge in MODA

  • Knowledge in Trackwise

  • Knowledge in PWS

  • Experience with lean manufacturing




Physical Position Requirements



Exposure to chemicals, fumes, odors, noise, live steam, temperature fluctuations, biohazards, continuous standing and lifting to a maximum of 50 lbs.


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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