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Senior Validation CQV Project Manager (cGMP – Pharmaceutical) JD820649

JD820649

DPS is seeking an established and knowledgeable Senior CQV Project Manager to work with a BioPharma client in the Southern NH area. Ideal candidates should have previous experience devising and implementing process and equipment validation strategy and authoring site validation master plans within cGMP capital project settings.

Category:
Engineer Commissioning & Qualification
Location:
New Hampshire
Years of Experience Req.:
8+
Date Posted:
15/03/2020
Days Remaining:
5
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior Validation CQV Project Manager (cGMP – Pharmaceutical)       JD820649

Southern NH area

 

DPS is seeking an established and knowledgeable Senior CQV Project Manager to work with a BioPharma client in the Southern NH area. Ideal candidates should have previous experience devising and implementing process and equipment validation strategy and authoring site validation master plans within cGMP capital project settings.

 

Responsibilities:

  • Provide technical project leadership for a major capital expansion project.
  • Responsible for delivering compliant documentation covering IQ/OQ and PQ as necessary as well as working with multi-disciplinary client and project team members to ensure the design, installation, commissioning and qualification of equipment, systems, and processes is conducted according to established quality and regulatory standards.
  • Analyz899799.696959e and resolve issues and provide guidance in delivery of Qualification/Validation services.
  • Develop/review all technical documentation and reports pertaining to systems and processes pertaining but not limited to: Design Qualification (DQ), Impact Assessments/Analysis (System and Component Level), Installation/Operational and Performance Qualification (IQ/OQ/PQ), etc.
  • Provide oversight in regard to project plans, scopes of work and related documents.
  • Will be involved in cross-functional agreement on best Engineering and C&Q approaches that are fit-for-purpose with consideration given to risk management, cost, and schedule.
  • Develop the CQV/Quality Schedule and associated deliverables associated with the project.
  • Work with Internal Project Team to determine the required internal structures and resource loading associated with the project from Planning through Implementation.
  • Generation/approval of a Project Validation plan to outline the project execution strategy plan.
  • Assist in the support and management of external vendor services.
  • Provide senior level technical support to staff/management on project activities as needed.

 

Qualifications & Experience:

  • Bachelor’s Degree in Science or related technical field.
  • Must have 8+ years of IQ, OQ, PQ qualification experience in a pharmaceutical environment.
  • Must have strong cGMP and GDP experience as well as capital project knowledge.
  • Must have strong, hands-on abilities as well as project management expertise.
  • Ability to lead but also plan, execute, and document projects independently.
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