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Job Description
Position Overview
This position provides direct validation support to biopharmaceutical development and manufacturing operations. This role performs validation activities accurately and completes documentation fully and compliantly.
Key Responsibility Areas
- Oversee Site Master Validation Program: Provide inputs to and administration of the site master validation program as well as assist in maintaining the site validation master plan; develop validation policy with roles and responsibilities; maintain validation life cycle approach for site
- Biopharmaceutical Validation: Author/Review/Execute process validation protocols and validation summary reports; perform validation testing and analyze data for validation documentation to determine acceptability, identify deviations and make appropriate notification
Specific Responsibilities
Responsibilities include, but are not limited to:
Equipment/Utility Qualification:
- Author/Review equipment qualification protocols and summary reports
- Author/Review executed equipment qualification protocols and summary reports
- Assist with execution of equipment qualification protocols
- Production oversight during validation events
- Work to ensure validation documentation becomes part of the site’s GMP documentation database
- Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout facility
Cleaning validation:
- Collaborate with manufacturing to design and develop cleaning procedures and processes for cGMP equipment used in the manufacture of pharmaceutical product
- Actively provide input and guidance in establishing a cleaning process for new products and partner with new product development engineers for process development
- Collaborate with the Cleaning Verification/Validation Analytical Group to develop and draft cleaning verification/validation protocols
- Review protocols, residue limits, reports and cleaning verification/validation summary packages
- Review new and/or updated Master Batch Records to evaluate the impact on Cleaning Validation Program
- Provides technical expertise for pre-validation risk assessments using risk management tools to evaluate specific requirements for the cleaning process involving new compounds
Process Validation
- Author/Review/Execute process validation protocols and summary reports
- Perform validation testing and analyze data for validation documentation to determine acceptability, identify deviations and make appropriate notification
Job Requirements
Key Competencies/Requirements
- Accountability, Agility, Creativity, Empowerment, Integrity, Passion, Attentive to Detail.
Qualifications
- Bachelor’s degree in a science or engineering related field
- 3-4 years of relevant experience in the pharmaceutical industry
- Recent experience in one or more of the following areas: process validation, equipment validation, CFR 210 Part 11 software validation or cleaning validation with at least one year of experience preparing and implementing process validation protocols and authoring validation summary reports.
