IPS – Integrated Project Services, Inc. Head of Qualification and Validation Pharma & Biotech in Frankfurt am Main, Germany
IPS is hiring! We are looking for a talented and energetic Head of Qualification & Validation to join our newly established German operations to be based at one of our offices either in Frankfurt or Nurember with remote working flexibility.
IPS Integrated Project Services is a global leader in EPMCV, solely specialized in Pharmaceutical / Biotech Engineering with offices on 4 continents and 1700+ professionals providing technical consulting, architecture, engineering, project controls, construction management, and CGMP compliance services for technically complex development and manufacturing facilities worldwide.
The Head of Qualification & Validation within the Commissioning & Qualification Division will be tasked with building, developing and leading a group of CQV experts, and will perform cGMP compliance based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements and will follow IPS and client standards and requirements, overall good industry practices and regulatory requirements. The individual may also perform standalone commissioning services for non-FDA regulated clients.
Job Duties & 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
C/Q/V Protocols and Summary Reports
Standard Operating Procedures
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 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.
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 utilise the IPS Best Practices and SOPs for delivery of compliance services.
Other duties as assigned.
Degree educated in Engineering or Natural Sciences discipline, preferably in Biology, Microbiology or Biotechnology
10+ years of industry experience in Pharmaceutical, Biotech, Medical Device Design, Commissioning or Validation.
Possess a minimum of 5 years of developing and leading either in direct or in project lead capacity teams of qualification and validation experts.
Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms and 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 EU and US FDA.
Proficiency with Microsoft Office applications.
Experience with cleaning, process, computer systems validation and other validation activities and processes is beneficial.
Experience with risk-based approach to commissioning and qualification is beneficial.
Must be fluent in English and German
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 1,700 professionals worldwide and offices in California, Indiana, Kansas, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, Canada, China, Germany, 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.
Street: Herriotstrasse 1