Qualification / Validation Expert

Position Responsibilities: IPS is hiring We are looking for a talented and energetic **Qualification / Validation (Q/V) Expert **to join our newly established Germany team to be based at our German offices located in Nurnberg & Frankfurt 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 **Q/V** **Expert** 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. **KEY ACTIVITIES 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) - FATS/SATs - 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 - 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. - Other duties as assigned. Qualifications & Requirements: - Degree educated in Engineering or Natural Sciences discipline, preferably in Biology, Microbiology or Biotechnology or related technical apprenticeship. - 5+ years of industry experience in Pharmaceutical, Biotech, Medical Device Design, Build, Commissioning and/or GMP/Validation discipline and understanding of processes and how they and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA. - Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software a plus. - Experience with Cleaning, Process, Computer System, Methods and other validation activities and processes - Fluency in English and German (minimum B2) **CONTEXT AND ENVIRONMENT AND SAFETY** - This position will require substantial travel, as required by an assigned project, being assigned to a client site for an extended period of time. Overnight travel or staying in the city of Client’s location is possible depending on assignment. Travel will be per the IPS Travel Policy, client specific travel policy or project specific travel plan. Position will visit Client sites and will be required to adhere to stated safety rules. Position may visit active construction sights and will be required to take site safety training and adhere to site safety rules. - This position is a safety sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research or other "non-administrative" areas. Company Overview: **About Us** **Specialties** 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)._