uniQure

Validation Manager - Lexington, MA

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Job

Active since 22-11-2017 Job category Engineering - Engineering
Location Lexington, MA Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
Place in the Organization:


The incumbent is responsible for ongoing development, maintenance, and oversight of the validation lifecycle as employed at the uniQure manufacturing facility in Lexington, Massachusetts. This includes commissioning, validation and qualification of the facility, equipment, utilities, environment, and process as well as preparation of all relevant documentation to meet industry standards and regulatory requirements for new and existing products. The incumbent will also provide supervision of all validation contract staff and Validation Engineers in accordance with all Company standards.

Key result areas (major duties, accountabilities and responsibilities):

  • Balance workload of and motivate direct reports and/or contract staff to accomplish department goals and objectives
  • Manage protocol generation, execution support, data analysis, report generation and approval for various installation, operational and performance qualification activities
  • Review and approve qualification documentation on behalf of the validation department
  • Ensure performance of all qualification activities is in accordance with internal procedures, industry and regulatory guidance
  • Lead investigations for protocol non-conformances
  • Provide Validation investigation for site deviations as required
  • Initiate and own validation related change controls, deviations, and corrective and preventative actions
  • Generate and maintain Validation program standard operating procedures
  • Support the generation and maintenance of Validation program guidance documents (Validation Master Plans)
  • Serve as Validation representative during execution of formal risk assessments
  • Represent the validation department at team meetings
  • Provide technical assistance and handle any questions or concerns from regulatory agency representatives in reference to validation of site equipment, utilities and facilities, and process validation
  • Support the Director of Engineering in maintenance of the departmental budget with relation to validation costs

Qualifications:

  • A minimum of a Bachelor’s degree in Life Sciences or Engineering
  • A minimum of 5 years of experience in qualification / validation of utilities, equipment, and processes in support of parenteral pharmaceutical or biopharmaceutical product manufacturing
  • A minimum of 2 years supervisory or leadership experience
  • Knowledge of regulatory (EMA, FDA) requirements and industry guidance (ISPE, PDA)

Core competencies:

  • The individual must have experience in multiple areas of Validation, including:
  • Commissioning
  • Computerized System Validation
  • Environmental Qualification
  • Sterilization Validation
  • Shipping Validation
  • Requalification
  • Process Validation
  • The individual must have experience in quality investigations (deviations, protocol non-conformances, etc.)
  • Familiarity with Microsoft Office
  • Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
  • Ability to manage multiple activities
  • Strong communication skills (written and verbal)

 

More information
This listing is a full-time job

Job category Engineering - Engineering
Industry / Industries Biotechnology
Region United States
Keywords Validation

Contact information

Name Jennifer Wagner

Location

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