Laboratory & Validation Specialist
Lincoln, NE - USA
Job Summary
Zoetis is the worlds largest Manufacturer and Supplier of Animal Pharmaceuticals.
At Zoetis in Lincoln NE we manufacture high quality medicines for companion animals and livestock. Our plant has been recognized as one of Nebraskas 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:
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 Laboratory & Validation Specialist position develops performs and documents troubleshooting calibration preventive maintenance and qualification activities on a diverse variety of new and existing bio-pharmaceutical equipment in support of Quality Operations testing laboratories and the sites Manufacturing facilities. Work is scheduled and executed in a largely self-directed manner while working closely with system owners to support Lincoln site engineering manufacturing and quality efforts.
Hours: 1st shift 7:30am 4:00pm (typical)
Position Responsibilities
- Performing qualification/revalidation activities on a wide variety of analytical/process equipment throughout the Lincoln site utilizing specialized testing methodology tools and instrumentation. Specific focus will be on equipment and processes utilized in the Quality Control laboratories.
- Development of validation test protocols and proper documentation evaluation of test results and summarization of testing data.
- Assuring that equipment / processes that require qualification/revalidation are in compliance with current Zoetis SOPs/standards GMP & USP guidelines and FDA USDA EU and other regulatory agency requirements.
- Execution and/or technical review of laboratory equipment calibration/performance data.
- Coordinating work activities with relevant stakeholders to maintain required schedules.
- Scheduling and managing outside equipment vendor installation and testing activities.
- Assisting internal customers (including cost center owners and engineering project managers) with specification of new equipment.
- Troubleshooting and facilitating repair of existing laboratory/process equipment.
- Developing documentation executing testing and otherwise contributing as necessary to equipment change controls and/or site investigational efforts.
- Participate in all relevant Engineering activities and training and utilize all systems necessary to complete assigned tasks.
- Interface with the Valgenesis qualification program Trackwise SAP Empower and other lab/production data acquisition systems for information input review and report generation.
Education and Experience
- Associate degree in engineering Science or closely related field required. Bachelors degree preferred. Equivalent experience will be considered.
- 3-5 years of relevant bio-pharma process and validation experience.
- Two or more years in an analytical testing laboratory performing wet chemistry testing or instrumentation testing including HPLC AA GC and UV/Vis preferred.
- Experience in qualification calibration and/or repair of analytical instruments.
- Experience with Empower data acquisition system preferred.
Technical Skills and Competencies Required
- Knowledge and experience in computerized laboratory systems instrumentation and equipment. Specific ability to operate and troubleshoot.
- Experience desired working with a variety of bio-pharmaceutical equipment/processes including autoclaves fermenters bioreactors depyrogenation tunnels coolers freezers incubators SIP CIP and VHP.
- Experience in writing and executing validation protocols for cGMP and cGLP facilities and equipment.
- Demonstrated proficiency in set-up and use of equipment normally used in calibration and validation including Kaye Validator and Valprobes.
- Demonstrated ability to plan and organize.
- Demonstrated ability to independently manage a variety of tasks at one time and bring them to completion on schedule.
- Demonstrated ability to interact with all levels of the department all levels of other departments consultants contractors and suppliers.
- Established knowledge of cGMPs cGLPs and USDA regulations.
Physical Position Requirements
- SAFELY work in an industrial environment.
- Physical conditions include lifting sitting standing and walking.
- Primary and secondary gowning changes required.
- Occasional weekend/off shift work as needed.
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.
Notice: Zoetis Recruiters will contact candidates via email from an address ending in @ and may also initially connect with candidates through LinkedIn including LinkedIn InMail. Zoetis does not use Gmail Outlook Yahoo or other web-based/generic email domains to communicate about job opportunities interviews or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @ please treat it as suspicious. For your security do not reply click links open attachments share personal or financial information or send money in response to unexpected or questionable recruitment communications.
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 site or (2) via email to/from addresses using only the Zoetis domain of @. 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 addition Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.Required Experience:
IC