We are seeking a C&Q Engineer/Specialist level candidate (5-7 years' experience)to join our IPS - Midwest team as a full-time, on-site resource for a large pharma client in the greater Elkhart, IN area (driveable for weekly commute). Ideal candidate will possess have experience with various equipment and systems including lab equipment/instrumentation, fermentors, chillers, etc. This is a Commissioning & Qualification Generalist role.
Job Duties and Responsibilities
Write C/Q/V documents following established Good Documentation Practices and standards, often using established templates, including but not limited to the following:
1) Commissioning Forms
2) C/Q/V Protocols and Summary Reports
3) Standard Operating Procedures
4) Impact Assessments
5) Specifications (URS/FRS/DDS)
Perform field/site activities including, but not limited to, the following:
1) Attend and witness FATs and SATs as a representative of IPS clients.
2) Execution of commissioning forms and witnessing of vendor start-up and testing.
3) Execution of C/Q/V protocols.
4) 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 process equipment and utility 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
• Special projects as assigned.
Additional Job Duties and Skills
• 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.
• Maintain professional conduct and deliver services in a professional and acceptable fashion.
• Become self sufficient and effectively work with limited supervision.
• Make recommendations to IPS for possible project and procedural improvements.
• Support and provide guidance for entry level staff and co-ops in the delivery of C/Q/V services.
• Stay current (training, reading, professional organization involvement) with industry trends and current C/Q/V methodologies.
• Other duties as assigned.
• Bachelor of Science in Engineering is required for an Engineer; Bachelor of Science in a related field is required for a Validation Specialist. Non-BS degrees will be evaluated on a case by case basis.
• 5 to 7 years of 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.
• 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.
• Proficiency with Microsoft Office applications (Word, Excel, Project, Powerpoint, etc.).
• Personal skills and traits include:
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 thirty 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 1,100 professionals worldwide and offices in California, Indiana, Kansas, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, Canada, China, Ireland, Singapore, Switzerland, UK and four locations in India. Visit our website at www.ipsdb.com.
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.
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.