CQV Specialist III

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry.

In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS' clients. You will also follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. Additionally, you may also perform standalone commissioning services for non-FDA-regulated clients.

Additional Responsibilities

• Write C/Q/V documents following established standards and templates, including but not limited to the following:
  
  • Commissioning Forms
  • C/Q/V Protocols and Summary Reports
  • Standard Operating Procedures
  • Impact Assessments
  • Specifications (URS/FRS/DDS)
  • FATS/SATs
• Perform field/site activities, including, but not limited to, the following:
  
  • Attend and witness FATs and SATs as a representative of IPS clients.
  • Execution of commissioning forms and witnessing of vendor start-up and testing.
  • Execution of C/Q/V protocols.
  • Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
  • Compile data and prepare reports for completed C/Q/V activities, including ETOPs, protocol data packages, etc.
  • Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
  • Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
• Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
• Read, understand, and utilize the IPS Best Practices and SOPs for the delivery of compliance services
• Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management of project status and issues, as requested.
• Other duties as assigned.

• 5+ years of relevant experience.

Preferred Qualifications

• Associates or bachelor's degree in a related field.
• Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
• General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.

Physical Demands

• Must be able to stand, sit, and walk for prolonged periods.
• Must possess the ability to stoop, kneel, crouch, and crawl as required.
• Must be able to lift and move objects weighing up to 50 pounds.
• Must be able to climb ladders as necessary.

Work Environment

• Must be able to work in both indoor and outdoor environments, which may include exposure to varying working conditions.
• Must be able to adhere to strict cleanroom gowning protocols.

Travel

• This position will have up to 100% travel, or as required by the assigned project.
• Position may be assigned to a client site for an extended period.
• Overnight travel or staying in the city of the Client's location is possible, depending on the assignment.
• Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
• Must have access to reliable transportation.

Safety

• This position is a safety-sensitive position.
• The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.

All interviews are conducted either in person or virtually, with video required.

IPS, a Berkshire Hathaway company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products. IPS, inclusive of its Enterprise entities, has over 3,500 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East. For further information, please visit www.ipsdb.com.

Specialties

Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV and Staffing Services.

All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.

Attention Search Firms / Third-Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via email, the Internet, or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.

If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!