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Commissioning and Qualification Specialist

1 month ago

Blue Bell, Pennsylvania, United States IPS-Integrated Project Services, LLC Full time
Job Description

This is a general application to the Commissioning, Qualification and Validation department at IPS-Integrated Project Services, LLC. The successful candidate will be responsible for performing cGMP compliance-based services, including commissioning, qualification, validation, consulting, and more.

Key Responsibilities
  • Document Creation: Write C/Q/V documents following established standards and templates, including commissioning forms, C/Q/V protocols, standard operating procedures, impact assessments, specifications, and more.
  • Field Activities: Perform field/site activities, including attending and witnessing FATs and SATs, executing commissioning forms and witnessing vendor start-up and testing, executing C/Q/V protocols, and more.
  • Primary Responsibilities: Commission and qualify equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
  • Quality and Compliance: Read, understand, and utilize IPS Best Practices and SOPs for delivery of compliance services, perform work to meet IPS budget requirements and quality standards, and provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management.
Qualifications and Requirements
  • Education: Associates or Bachelor degree in a related field is preferred.
  • Experience: 2 or more years of relevant experience in pharmaceutical, biotech, medical device design, construction, commissioning, validation, or QA.
  • Skills: Proficiency with Microsoft Office applications, personal skills and traits including a sense of urgency, team player, able to multi-task, effective time management, able to effectively prioritize, good interpersonal skills, attention to detail, excellent customer service skills, and more.
Travel and Safety
  • This position will have up to 100% travel, or as required by the assigned project.
  • Position may be assigned to client site for an extended period of time.
  • Overnight travel or staying in the city of Client's location is possible depending on assignment.
  • Position will visit Client sites and will be required to adhere to stated safety rules.
  • Position may visit active construction sites and will be required to take site safety training and adhere to site safety rules.