CQV, General Application

This is a general application to our Commissioning, Qualification, and Validation department. Please see below for job duties if hired.

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. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. May also perform standalone commissioning services for non-FDA regulated clients.

What You'll Do

• 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 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.

• Associates or Bachelor's degree in a related field preferred
• 2 or more years of relevant experience.
• 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 is a plus.
• 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 helpful.

Context & Safety

• This position will have up to 100% travel, or as required by the assigned project.
• Position may be assigned to the client site for an extended period of time.
• 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.
• 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.
• 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.

FTE

IPS offers a comprehensive benefits package designed to support your health, financial well-being, and professional growth. Our benefits include medical, dental, and vision insurance, life and disability coverage, a 401(k) plan with company match, paid time off, paid holidays, flexible spending accounts, and educational assistance.

PBE

IPS offers a benefits package designed to support your health, financial well-being, and work-life balance. Our offerings include comprehensive medical and vision insurance, a 401(k) plan, and paid time off.

IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.

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.

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