Lead Validation Engineer I bei Commercial
Commercial · Wilmington, Vereinigte Staaten Von Amerika · Onsite
- Professional
- Optionales Büro in Wilmington
Support efforts to prove control of the critical aspects of Alkermes operations with a focus on process and cleaning validation. Function as subject matter expert in process and cleaning validation for pharmaceutical products. Lead and structure scientific debate and assessment with peers from other technical areas to develop scientific understanding. Determine levels of importance or risk to be assigned to elements under review using scientific rationale to justify scale of effort. Demand / extract appropriate definition of science underpinning element (product, process, equipment, cleaning regime) under review. Present clear picture of validation efforts to reviewers and auditors, providing confidence in the installed equipment, process, equipment, facility or procedure. Represent the Validation group in certain forums. Contribute to validation policies, guidance documents (SOPs, VMPs, VPPs) detailing best practice approach and implement these throughout the site. Understand best industry practice, current developments and opportunities arising for Alkermes. Contribute to the maintenance of GMP compliance through monitoring, review, assessment and qualification of activities. Contribute in areas such as change control, PPI’s, APR’s, and PR’s, VMP’s and SOP updates and attendance in forums such as review boards and KPI reviews. Review prospective changes for validation impact and required implementation validation actions. Department representation on deviations/ investigations and determination of impact to validated state. Understand the science and areas of technical knowledge that underpin area of focus and apply this knowledge in the development of validation approach and in the presentation, documentation and review of outcome. Ensure validation systems (policies, procedures, reviews, VMPs, etc.) meet current / changing industry demands. Responsible for the maintenance of validation systems and ensuring compliance of validation corrective actions.
Qualifications
Bachelor’s degree in Pharmaceutical Science, Biomedical Science, Biomedical Engineering or related field and five years of experience in validation experience in pharmaceutical field. Experience must include three years each of the following: defining validated cleaning campaign lengths including Clean and Dirty Hold Times; process and cleaning of microsphere equipment; and use of deviation, change management, and electronic documentation management systems in commercial pharmaceutical cGMP MoH regulated industry. Experience must include one year each of the following: OSD cleaning sampling, wearing of gowning PPE including respirator used in manufacturing areas utilizing potent compounds; cleaning validation sample collection; statistical process evaluation utilizing JMP software or other statistical software; statistical analysis; Valgenesis, Veeva, and Trackwise; and applicable regulatory requirements for Process/Cleaning Validation. Experience may be gained concurrently.
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