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Validation Engineer/Specialist II

4 months ago

Minneapolis, Minnesota, United States IPS - Integrated Project Services, LLC Full time
Job Description

At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Validation Engineer II to join our talented team at our office located in Minneapolis, Minnesota.

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.

What You'll Do

  • 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 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.
  • 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 the 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.

Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights

Qualifications & Requirements
  • 2+ years of relevant experience.
  • Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
  • Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).

Preferred Qualifications

  • Associate or Bachelor's degree in a related field.
  • Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/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/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.

Context and Safety

  • This position will have up to 100% travel, or as required by the assigned project.
  • You may be assigned to the client site for an extended period.
  • Overnight travel or staying in the city of the Client's location is possible depending on the assignment.
  • Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
  • You may visit active construction sites 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.
About Us

IPS, a Berkshire Hathaway Company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products. Its newest acquisition, Linesight, specializes in cost, schedule, risk, program, and project management services in various market sectors, including data centers, life sciences, and high-tech industries. With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East.

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.

All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.

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.

#LI-RR1

IPS is an equal opportunity, affirmative action employer of protected veterans (M/F/D/V).