Validation Specialist

Cambridge, MA, United States
Oct 09, 2018
Required Education
Bachelors Degree
Position Type
Full time
Validation Specialist

Ipsen Bioscience, Inc.

Job Description:

Position Overview:

To define and implement the qualification strategy to establish and maintain the validated status of facilities, utilities, equipment and processes. To lead the validation activities associated with specific project

Job Responsibilities:
  • Ensure the validated status of site facilities, utilities, equipment and processes is established and maintained in accordance with internal procedures, regulatory requirements and industry guidance / standards.
  • Define and execute the validation strategy associated with site projects covering a range of facilities, utilities, equipment and processes in accordance with project timelines and customer expectations.
  • Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation. This includes changes to corporate quality guidance and standards.
  • Present validation packages during regulatory / internal / customer audits. Participate in the response to regulatory audit observations (as required).
  • Drive a risk based validation lifecycle utilising quality risk management principles and tools (e.g. FMEA, HAZOP) to ensure that risks are appropriately identified and documented.
  • Provide expertise for the investigation and compliant resolution of non-conformances encountered during (re)qualification / (re)validation activities and site Unplanned Events.

  • Bachelors Degree in Engineering, Science or relevent life sciences
  • Minimum of 7+ years in CQV experience in cGMP manufacturing environments
  • Extensive knowledge of quality systems and performing validation impact assessments
  • Strong understanding of validation principles including but not limited to FEU, cleaning, process, computer systems and shipping
  • Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection
  • Able to work effectively as a part of a cross-functional team and maintain good relationships with internal and external stakeholders

Ipsen Bioscience, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.