Biotechnology Validation Specialist
PSC Biotech provides life sciences with essential services ensuring health care products are developed, manufactured and distributed to the highest standards in compliance with regulatory requirements.
We are looking for a Commissioning Qualification and Validation Engineer. This professional will work alongside a talented team in an exciting, developing and diverse biotechnology landscape.
Requirements
* Commission, qualify and validate GxP facilities, equipment and utilities in assigned projects.
* Draft and execute validation documentation such as validation project and master plans, requirement specifications, IQ/OQ test scripts, IQ/OQ/PQ protocols and validation summary reports.
* Conduct preventative maintenance and perform risk assessments.
* Recommend process improvements ensuring compliance with industry standards.
* Establish validation standards and develop performance testing and quality control measures.
* Execute process equipment and clean room validation.
* Candidate should have a Bachelor's Degree in a relevant science or engineering field or equivalent years of hands-on experience.
* Should have 3+ years' experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within a GMP environment.
* Experience in authoring, revising, reviewing and completing controlled documents for validation projects is necessary.
Benefits
Competitive salary, comprehensive benefits package and opportunities for professional growth and development.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance
Skills and qualifications
* Bachelor's degree in a relevant science or engineering field or equivalent years of hands-on experience.
* 3+ years' experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within a GMP environment.
* Experience in authoring, revising, reviewing and completing controlled documents for validation projects.
* Strong written and verbal communication skills.
* Excellent organizational skills.
* High attention to detail.