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