Validation Services Specialist

TN United Kingdom; Lincoln; On-site; GBP 35,000 - 55,000; Full time

Job summary

An established industry player in the bio-pharmaceutical sector is seeking a Validation Services Specialist to join their innovative team in Lincoln. This role involves planning and executing validation testing on a variety of cutting-edge equipment, ensuring compliance with stringent industry standards. The ideal candidate will have a strong background in bio-pharmaceutical processes and validation, along with the ability to work independently and manage multiple tasks effectively. With excellent benefits including paid vacation and tuition reimbursement, this position offers a fantastic opportunity for professional growth in a dynamic environment.

Benefits

4 weeks paid vacation

401(k) match

Tuition reimbursement

Great health benefits

Paid holidays

Qualifications

• 3-5 years of relevant bio-pharma process and validation experience.
• Ability to independently manage a variety of tasks and bring them to completion.

Responsibilities

• Performing verification/validation activities on bio-pharmaceutical equipment.
• Developing test protocols and summarizing testing data for compliance.

Skills

Validation Testing

Bio-pharmaceutical Equipment

Documentation Skills

cGMP Knowledge

Project Management

Education

Associate Degree in Engineering

Bachelor's Degree in Science

Tools

Kaye Validator

Valprobes

SAP

Trackwise

Job description

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About Zoetis

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 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:

• 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.

Position Summary

The Validation Services Specialist position is responsible for planning, developing, and performing validation and revalidation testing on a diverse variety of new and existing bio-pharmaceutical equipment and facilities. Work is scheduled and executed in a largely self-directed manner, while working closely with system owners to support the Lincoln site engineering, manufacturing, and quality efforts.

Hours:

1st shift, 7:30am – 4:00pm (typical)

Position Responsibilities

• Primary responsibility will be performing verification/validation/revalidation activities on a wide variety of equipment throughout the Lincoln site, utilizing specialized testing tools and instrumentation.
• Development of test protocols and proper documentation, evaluation of test results, and summarization of testing data.
• Assuring that equipment / processes that require revalidation are in compliance with current SOP’s, GMP guidelines, and FDA, USDA, EU, and internal Zoetis standards.
• Coordinating work activities with relevant stakeholders to maintain required schedules.
• Assisting customers (including cost center owners and engineering project managers) with specification of new equipment and troubleshooting of existing equipment that require validation/revalidation.
• 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, and SAP for data input and report generation.

Education and Experience

• Associate degree in Engineering, Science or closely related field required. Bachelor’s degree preferred. Equivalent experience will be considered.
• 3-5 years of relevant bio-pharma process and validation experience.

Technical Skills and Competencies Required

• Demonstrated proficiency in set-up and use of equipment normally used in calibration and validation, including Kaye Validator and Valprobes.
• Experience working with a variety of bio-pharmaceutical equipment/processes including autoclaves, fermenters, bioreactors, depyrogentation tunnels, coolers, freezers, incubators, SIP, CIP, and VHP.
• Experience in writing and executing validation protocols for cGMP facilities.
• 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, EU, 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.

Note: The duplicate sections and inconsistent list formats have been standardized for clarity. Additional irrelevant or repetitive content has been removed to focus on the core job description and requirements.