IPS is hiring! We are looking for an experienced Lead Validation Engineer to join our industry leading EMEA Commissioning, Qualification and Validation (CQV) team to be based out of our EMEA headquarters located in Birmingham, UK
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. Interfaces directly with IPS clients in the delivery of projects including routine communications, leading project meetings, tracking and reporting project metrics (financial and deliverables), self-directing and directing of assigned project team, maintains positive client relationship, etc. May also manage and perform standalone commissioning services for non-FDA regulated clients.
Job Duties and Responsibilities
- Assist an assigned Project Manager or is directly responsible for the successful delivery of compliance projects to IPS’ clients. Leads independent (sole individual), small or mid-sized projects on behalf of IPS.
- IPS point of contact to client for day to day project delivery. Runs meetings, communicates status and project issues, frequently “checks-in” with client representative(s) and facilitates general project coordination activities.
- Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete and timely feedback and reports to IPS project managers or management of project status and issues. Develop project schedules, deliverable tracking reports, scope adjustment notices, etc.
- Support, train and provide guidance to validation specialists/engineers in the delivery of C/Q/V services for assigned projects.
- Write and manage others in the preparation of C/Q/V documents following established standards and templates, including but not limited to the following:
- C/Q/V Master Plans
- Commissioning Forms
- C/Q/V Protocols and Summary Reports
- Standard Operating Procedures
- Impact Assessments
- Specifications (URS/FRS/DDS)
- Perform and manage others during 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.)
- Perform and manage staff in compiling data packages and preparing 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.
- Coordinate with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
- Audit project deliverables to assure compliance with established standards. Review work of assigned project team.
- Assist in proposal development including scope definition, attend bid meetings, development of hours and cost budgets, proposal presentations, etc.
- Act as an IPS representative for developing new opportunities and continue to support repeat business.
- Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech and medical device industries.
- Must be self-sufficient and effectively work with limited to no supervision.
- Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services.
- Demonstrated/recognized areas of expertise by industry (Sterile, OSD, Biotech, Medical Device), by equipment/systems (lyophilizers, autoclaves, packaging, compression/encapsulation, etc.), or by validation activity (process, cleaning, CSV, methods, etc.). Provide working knowledge in the delivery of technical projects in these areas.
- Develop client relationships and act as IPS liaison (point of contact) on project/client sites. Seek new opportunities for IPS with existing contacts.
- Maintain professional conduct and deliver services in a professional and acceptable fashion.
- Assist in recruiting new staff members and promoting IPS to potential hires.
- Make recommendations to IPS for possible project and procedural improvements.
- Stay current (training, reading, professional organization involvement) with industry trends and current C/Q/V methodologies.
- Special projects 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.
- Minimum of 10 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 and protocols for GMP Utilities, Equipment, Systems and Software.
- Experience with Cleaning, Process, Computer System, Methods and other validation activities and processes is beneficial.
- 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.
- Experience with Risk-Based Approach to Commissioning and Qualification is beneficial.
- Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
- Demonstrated knowledge of Project Management Principles required.
- 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 1,300 professionals worldwide and offices in California, Kansas, Maryland, 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.