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Validation Engineer

Location
Boston, Massachusetts
Posted
7 Sep 2022

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.


IPS is a multi-national company with over 2,500 professionals worldwide and offices in California, Kansas, Maryland, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, Canada, China, Ireland, Singapore, Switzerland, Germany, United Kingdom and four locations in India. Visit our website at


Position Responsibilities

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

  • Bachelor's Degree in Engineering or Science preferred.
  • 0 to 2 years of relevant experience minimum.
  • 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 a plus.
  • 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 helpful.


Context and Environment/Safety

  • This position will have up to 100% regional travel, or as required by the assigned project. Position may be assigned to client site for an extended period of time. Most projects within this region are located within 30 miles from the IPS site. 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.



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).

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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Details

  • Job Reference: 706060207-2
  • Date Posted: 7 September 2022
  • Recruiter: IPS-Integrated Project Services
  • Location: Boston, Massachusetts
  • Salary: On Application