CQV, General Application
About The Position
This is a general application for the Commissioning, Qualification, and Validation (CQV) department. In this role, you will perform cGMP compliance-based services, including commissioning, qualification, validation, and consulting, as defined in project agreements with IPS clients. You will adhere to IPS and client standards, good industry practices for C/Q/V services, and regulatory requirements. The role may also involve standalone commissioning services for non-FDA regulated clients. Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting the pharmaceutical, biotech, and medical device industries. You will read, understand, and utilize IPS Best Practices and SOPs for compliance services, work to meet IPS budget requirements and quality standards, and provide timely feedback and reports to IPS project leaders, managers, or management. Other duties may be assigned.
Requirements
- 2 or more years of relevant experience.
- Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
- 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.
- Must adhere to stated safety rules at client sites.
- Must take site safety training and adhere to site safety rules if visiting active construction sites.
- Must have video capability for virtual interviews.
Nice To Haves
- Associates or Bachelor's degree in a related field preferred.
- Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software is a plus.
Responsibilities
- Write C/Q/V documents following established standards and templates, including Commissioning Forms, C/Q/V Protocols and Summary Reports, Standard Operating Procedures, Impact Assessments, Specifications (URS/FRS/DDS), and FATS/SATs.
- Perform field/site activities, including attending and witnessing FATs and SATs as an IPS client representative, executing commissioning forms, witnessing vendor start-up and testing, executing C/Q/V protocols, and performing walkdowns and verification of system drawings (P&IDs, as-builts, etc.).
- Compile data and prepare reports for completed C/Q/V activities, including ETOPs and protocol data packages.
- 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.
- 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.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life coverage
- Disability coverage
- 401(k) plan with company match
- Paid time off
- Paid holidays
- Flexible spending accounts
- Educational assistance
- Pay for certifications 75% and give raises after completion.
- Referral bonuses ($5,000)
- Reimburse one industry membership fee 100% per year (e.g., AFCOM and BCxA).
- Pay billable overtime after 40 hours at a straight time rate (even as an exempt salary employee).
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
