Validation Engineer

HIghly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)
  3. United States
St. Louis, USA
Posting date: 01 Dec 2020
QA.BC.34473

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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