AMRI Manager, Validation Engineering in Burlington, Massachusetts

The Manager, Validation is responsible for the direct management of validation activities. These include validation of equipment and facility support systems (steam, water, BMS). Coordinating with functional area management to ensure equipment/staff availability to ensure timely completion of PM and Qualification activities. Ensure on-time and on-budget completion of validation/metrology activities.

Position Responsibilities

/Other duties may be assigned/

  • Scheduling, oversight and performance of validation activities at AMRI.

  • Supervise validation personnel

  • Participation on customer specific project teams as needed

  • Oversee and occasional assistance of execution of Validation protocols.

  • Participate in regulatory and client audits.

  • Must be skill in the use of computers, software and spreadsheets.

  • Oversight of the equipment and facility validation functions.

  • Oversight of process validation, cleaning validation and equipment validation by working with appropriate internal departments

  • Bachelor’s degree in Pharmaceutical-related science or engineering discipline.

  • Excellent working knowledge of FDA cGMPs (21 CFR, 211, 820, and / or 600); Annex 1, EN 285, ISO 9001 and 13485 a plus.

Education:Bachelor’s degree in Pharmaceutical-related science or engineering discipline.

Relevant Work Experience:

  • Minimum of 5 years supervisory/management and/or project management experience in a pharmaceutical company

  • Minimum of 10 years industry experience in a cGMP environment with direct equipment/facility validation experience

Knowledge, Skills & Abilities:

  • Familiarity with validation tools and processes, including temperature mapping and use of Kaye Validator

  • Familiarity with FDA and EU regulations for pharmaceuticals and medical devices

  • Strong technical writing skills are required to author validation documentation

  • Ability to work semi-independently; demonstrated ability to interact well with other technical departments

  • Previous experience in the review of validation (process, IOPQ) protocols and reports is required.

  • Excellent communication skills

Job: *Quality

Organization: *AMRI Burlington

Title: Manager, Validation Engineering

Location: MA-Burlington

Requisition ID: 1001048

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