Validation Engineer job in St. Louis, USA

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Validation Engineer with a pharmaceutical company located in St. Louis, MO.

Job Responsibilities:

Responsible for the development, planning, implementation, qualification and validation for the manufacturing, packaging, facilities, computer, and cleaning processes in place.
Write, review and execute documentation to conduct all validation activities to support new product launches and maintain existing product validations.
Requires expertise in regulatory compliance, ability to determine requirement to validate and discern appropriate level of validation for the process.
Determine cause/effect relationship between equipment modifications and product efficiency.
Develop, update, and maintain the Site Validation
Coordinate resources needed to complete validation tests.
Provide validation support during the design, evaluation, and procurement stages.
Monitor validation criteria and assure compliance.
Prepare presentations for regulatory agencies regarding the validation program and its status.
Provide technical expertise and facilitate documentation assembly during regulatory audits.
Develop and conduct validation training programs for associates.
Collaborate with Engineering on the development of User Required Specifications and Installation and Operational Qualification documents.
Write and execute process, packaging, computer, facility, and cleaning validation protocols and summary reports.
Interface with Manufacturing, Packaging, Logistics, and Engineering to facilitate and drive protocol execution.
Author, review, revise, or approve Standard Operating Procedures (SOPs) as required.
Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the validation team.
Interface with and coordinate activities of validation contractors.

Skills and Requirements:

Bachelors degree in a technical or scientific discipline or related work experience.
Minimum 5 years experience in Manufacturing validation and the Pharmaceutical or Healthcare Industry required
Working knowledge of cGMP regulations.
In depth knowledge of process, packaging, facility, and cleaning validation.
Good computer skills and Microsoft Word, Excel, PowerPoint, and Statistica (as a plus).

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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