Position Responsibilities:IPS is searching for junior-to mid level (3-5 yrs experience) Validation Engineers/Specialists to join our Midwest team in the greater Columbus, OH area
. Will perform cGMP compliance based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. The Validation Engineer(s)/Specialist(s) will follow IPS and client standards and requirements, overall good industry practices and regulatory requirements.
The successful candidate will have experience working in the pharma and/or biotech industries with Oral Solid Dosage background; facility/utility Commissioning and Qualification protocol development/execution experience is also a plus. Additional experience with Design Review / Design Qualification, Risk Assessments, User Requirements Specifications, and Traceability Matrix development is preferred.
Additional duties include:
- Write C/Q/V documents following established standards and templates.
- Perform field/site activities such as: 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.
- Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
- Assists in deviation investigation and resolution for problems and issues encountered during field execution activities.
- Coordinate with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
- 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.
- Provide consistent, complete and timely feedback and reports to IPS project leaders, project managers or management of project status and issues.
- Bachelor of Science in Engineering is required for an Engineer; Bachelor of Science in a related field is required for a Specialist role.
- 3-5 years of industry 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 and protocols for GMP Utilities, Equipment, Systems, and Software.
- Oral Solid Dosage experience is preferred.
- 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 EU and US FDA.
- Proficiency with Microsoft Office applications.
- Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes is beneficial.
- Experience with Risk-Based Approach to Commissioning and Qualification is beneficial.
Company Overview:IPS-Integrated Project Services is a global leader in developing innovative and cost effective solutions for the engineering, construction, commissioning and qualification of complex pharmaceutical and biotech research and manufacturing facilities. With technical expertise spanning R&D to pilot-scale to large-scale production, our team specializes in the technology, trends and regulatory environment to successfully deliver capital projects and improve operations. For over twenty years, we have applied unique LEAN methodologies throughout the project life cycle, continually finding ways to do things better and more efficiently, delivering higher quality and controlling costs. Headquartered in Blue Bell, PA, IPS is a multi-national company with over 700 professionals and offices in Indiana, Massachusetts, New Jersey, North Carolina, Brazil and four locations in India. Visit our website at www.ipsdb.com
Architectural Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program Management, Operations/Logistics Strategy and Planning, EPCMV IPS is an equal opportunity, affirmative action employer of protected veterans (M/F/D/V). 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.
IPS-Integrated Project Services is a full-service engineering firm dedicated to helping clients succeed with capital projects and improve operations. We specialize in complex facilities in hi-tech and highly regulated industries providing Knowledge, Skill and Passion in the areas of Technical Consulting, Engineering, Construction, Commissioning and Qualification. IPS will be the Knowledge Leaders of Choice by delivering Technology-based Business Solutions which help our Clients Succeed. To be the Knowledge Leader, we continue to push ourselves in new and exciting directions. Our Vision, Mission and Values were developed to help guide our actions.