Commissioning & Qualification

Location: Philadelphia, New York, New Jersey, DC area

Job Description

Commissioning & Qualification Specialists provide technical and project support for Installation Qualification (IQ), Performance Qualification (PQ) and Operational Qualification (OQ)  in the design, installation, commissioning and qualification of equipment, systems, and processes according to established quality and regulatory standards. Duties include but are not limited to:

  • Analyze and resolve issues and provide guidance in the delivery of Qualification/Validation services
  • Develop/review technical documentation and reports pertaining to systems and processes including but not limited to:
    • Impact and Critical Aspect Assessment; Commissioning Forms/Test Packs/Protocols and Factory/Site Acceptance Tests; Risk Assessment and Gap Analyses;Quality Plans and Policies;Standard Operating Procedures (SOPs), Summary Reports;Validation Master Plans, IQ/OP/PQ SpecificationsImpact Assessments/Analysis (System and Component Level)


Qualifications

  • College degree in technical discipline and five plus years of Commissioning/ Validation experience with equipment and systems used in pharmaceutical manufacturing.
  • Experience in writing/execution of Equipment and Systems/Software protocols
  • Knowledge/understanding of regulatory requirements of GMP/FDA systems & equipment
  • Proficiency with diverse equipment and software operations
  • Good organization, communication, and interpersonal skills and ability to effectively work with clients and staff in fast-paced project team environment