Validation Associate

Jubilant HollisterStier LLC provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is owned by Jubilant Life Sciences.

The Validation Associate works closely with the Validation Specialist in support of capital, contract, and compliance projects. This position is responsible for executing a variety of validation studies, including performance qualifications and/or requalification’s for terminal and component sterilization work. Other essential responsibilities include:

Assist with writing and executing applicable validation protocols associated with the given project.

Author relevant acceptance reports for the respective protocols.

Provide timely and accurate updates to the respective project leader/project team with regard to validation activities.

Once validation efforts are complete for given equipment or process, ensure applicable SOP(s) are updated and reflect results stated in approved acceptance report(s).

Provide validation support to project teams involved in facility and utility expansion, compliance upgrades, cost reduction, contract manufacturing, process improvements, construction projects, etc.

Through education and experience possess a working knowledge of the operation of equipment and systems. This includes, but is not limited to, equipment and systems such as mix tanks, autoclaves, dry heat ovens, vial and stopper risers, CIP and SIP systems, HVAC systems, aseptic processing areas, etc.

Utilize excellent communication skills, including the ability to organize and write detailed protocols and reports. This includes the ability to use Good Documentation Practices to document the validation of systems and equipment.

Properly apply knowledge of current industry practices and cGMP requirements with regard to the validation of equipment and systems.

Possess the interpersonal skills necessary to work with project team members from various disciplines. This includes Manufacturing, Quality Assurance, Regulatory Affairs, Engineering/Maintenance, and Technical Services.

Work closely with user departments to schedule validation tasks in a manner which maximizes the efficiencies of the study, while having minimal impact on the routine operations of the user department.

Validation Associate may be required to execute validation work on production equipment during non-production times. This may result in a need to flex work times to cover evenings or weekends on occasion.

Qualifications:

Associate of Science degree required –OR– 3 years of related experience in lieu of degree. Bachelor of Science is desired.

Must have at least 6 months of related experience. 1 year is desired.

Prior pharmaceutical and FDA related industry experience desired.

Manufacturing production and equipment operation experience required.

Proficiency in Microsoft Word and Excel required. (Microsoft PowerPoint desired.)

Knowledge of other programs like SAP and ETQ is desired.

Mechanical required.

Physical Requirements: Lift up to 40 lbs unassisted. Exposure to allergens, working in aseptic areas, working in confined spaces, and repetitive activity. Pushing, pulling, and twisting. Prolonged standing

Jubilant HollisterStier is a great place to grow!

If you’re up for a rewarding challenge, we invite you to take the first step and apply today!

https://www.jubilantcareer.jubl.com

Jubilant HollisterStier is an EEO/AA Employer.

All qualified applicants will receive consideration for employment without regard to their protected veteran status and will not be discriminated against on the basis of disability.

If you require assistance applying for a position, please contact our HR Department at:

HResources@jhs.jubl.com