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Senior Validation Specialist

IPS Integrated Project Services, LLC
Closing date
23 Feb 2021

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Job Details

Position ResponsibilitiesIPS is hiring! We are looking for a talented Senior Validation Specialist to join our industry leading Commissioning, Qualification and Validation (CQV) team to be basedat our EMEA HQ 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. May also perform standalone commissioning services for clients.

Job Duties And Responsibilities
  • 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.
  • Provide consulting based services in areas of expertise.
  • Support, train and provide guidance to validation specialists/engineers in the delivery of C/Q/V services and areas of expertise.
  • Write 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) 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.
  • 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.
  • Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech and medical device industries.
  • Be self-sufficient and effectively work with limited supervision.
  • Read and understand 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
  • Assist the project leader and/or project manager with project management activities, (schedules, attend/lead meetings, maintenance of budgets/deliverables).
  • Act as an IPS representative for developing new opportunities and continue to support repeat business.
  • Develop client relationships and act as IPS liaison (point of contact) on project/client sites.
  • Assist with site auditing and cGMP consulting based services.
  • 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. Present at industry / trade organization seminars.
  • Special projects 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. Non-BS degrees will be evaluated on a case by case basis.
  • Minimum of 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 and protocols for GMP Utilities, Equipment, Systems, and Software.
  • Experience with Cleaning, Process, Computer System, Methods and other validation activities and processes.
  • 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

About Us Company OverviewIPS-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 1,400 professionals worldwide and offices in California, Indiana, Kansas, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, Canada, China, Ireland, Singapore, Switzerland, UK, Germany and four locations in India. Visit our website at .

SpecialtiesProcess Architecture, Process Design, En gineering, 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.

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