Responsibilities

Job Description: Serve as a subject matter expert in and lead equipment, facility, and utility qualification for clinical and commercial pharmaceutical manufacturing and laboratory systems. Serve as technical lead for maintenance of GMP compliance through monitoring, review, assessment and qualification of activities. Ensure Validation systems (policies, procedures, reviews, VMPs) effectively meet current/changing industry demands. Oversee maintenance of validation systems and compliance of validation corrective actions. Define validation strategy in accordance with company procedures and policies. Contribute to change control, deviations/investigations, VMP, work order assessments, and SOP updates. Generate validation policies and guidance documents detailing best practice approach and implement these throughout the site. Communicate proactively with team members, stakeholders, and management regarding progress, issues, and plans for resolution to ensure the project team is fully informed. 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. Present coherent and clear picture of validation effort to any reviewer or auditor. Understand best industry practice, current developments and opportunities arising for Alkermes. Mentor validation engineers on the team. Proactively implement current validation practices with focus on impact to patient safety, product quality, and data integrity.

Qualifications

Salary: $135,000 - $150,000

Requirements: Bachelor's degree in Pharmaceutical Science, Biomedical Science, Biomedical Engineering or related field and eight years of validation experience in the pharmaceutical industry. Experience must include five years each of the following: performing equipment, facilities, and utilities qualification/validation in commercial pharmaceutical cGMP MoH regulated industry; using deviation, change management, and electronic documentation management systems; Valgenesis, Veeva, Maximo, or Trackwise; temperature mapping data logging systems and software, such as Ellab, Val Probe, Kaye validator AVS or 2010, TMI-Orion, or Temptale; root cause analysis tools; wearing gowning PPE used in aseptic and non-aseptic manufacturing areas; and performing risk analysis/assessment. Experience may be gained concurrently.

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