Job Description
- 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.
Qualifications & Requirements
- 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.
Additional Incentives
- Pay for certifications 75% and give raises after completion.
- Pay $5,000 referral bonuses.
- Reimburse one industry membership fee 100% per year like AFCOM and BCxA.
- Pay billable overtime after 40 hours at a straight time rate - even as an exempt salary employee.
The salary range for this role is $79,7500 to $122,250, depending on experience and skills.
