IPS-Integrated Project Services ยท 2 weeks ago
Validation Engineer II
Indianapolis, IN
Full-time
Onsite
Entry Level
2+ years expIPS-Integrated Project Services is a global leader in technical consulting and engineering services, primarily in the life sciences industry. They are seeking a Validation Engineer II to perform cGMP compliance-based services and support pharmaceutical, biotech, and medical device industries by executing commissioning and validation protocols.
ArchitectureConstructionConsultingProcurement
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
Qualification
Required
Bachelor of Science in Engineering
2+ years of relevant work experience
This is an entry-level position
Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA
Preferred
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/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA
Company
IPS-Integrated Project Services
IPS-Integrated Project Services, LLC, a Berkshire Hathaway company, is a global leader in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities.
1001-5000 employees
H1B Sponsorship
IPS-Integrated Project Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (18)
2024 (4)
2023 (6)
2022 (8)
2021 (3)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2015-11-02Acquired
Leadership Team
Dave Goswami
Global CEO and Chairman of IPS Enterprise
Recent News
24-7 Press Release Newswire
2025-04-12
2024-04-09
Company data provided by crunchbase