IPS is hiring! We are looking for a talented Validation Engineer I to join our industry leading Validation/Compliance team at our office located in Somerset NJ.
This position requires project travel throughout the NJ area.
Performs 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.
Job Duties and 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)
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.
Special projects as assigned.
A d d itional 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.
Qualifications & Requirements
Bachelor of Science in Engineering is required for an Engineer; Bachelor of Science in a related field is required for a Validation Specialist.
1 to 3 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:
- Sense of urgency - Team player - Able to multi-task - Effective time management - Able to effectively prioritize - Good interpersonal skills - Attention to detail - Excellent customer service skills
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.