IPS – Integrated Project Services, Inc.

  • Job Locations US-PA-Allentown
    ID
    2018-3336
    Department
    CQV - Validation
    # of Openings Remaining
    1
    Position Type
    Regular Full-Time
    Location : Location
    US-PA-Allentown
  • Position Responsibilities

    IPS is hiring! We are looking for a talented Lead Computer Systems Validation Engineer to join our industry leading Commissioning, Qualification and Validation (C/Q/V) team at our client site located in Allentown, PA. Must be local to the Allentown area- this position does not cover T&L.

     

    Must have experience in the pharmaceutical industry. Must be a proficent user in LIMS. 

     

    • Act as a CSV and/or computerized/automated systems compliance lead on client project
    • Author the typical validation and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, URS/FRS, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and scripts, Testing Defects, etc.
    • Oversee and coordinate the systems testing efforts
    • Act in a leadership capacity: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, etc.
    • As may be requested, participate in Computerized System Compliance activities other than CSV, such as procedures development, infrastructure qualification, vendor assessments, etc.
    • As may be requested, support services sales cycle by participating in such activities as solution analysis, proposal writing, etc.

    Qualifications & Requirements

    • 7+ years of computerized systems compliance and CSV experienced in life sciences space is required.  10+ years are desired
    • Understanding of GxP and Computer Systems / Automation role in support of GxP compliance is required
    • Understanding of GAMP5 and risk-based approach to validation is required
    • Knowledge and understanding of relevant regulations, such as Part 11, Annex 11, Part 211, etc., is required
    • Experience with manufacturing automation systems is highly desired
    • Ability to identify, define and propose the quality framework improvements based on daily challenges is desired
    • Experience with services sales cycle activities is desired
    • Excellent communication and written skills required
    • Ability to travel to client locations is highly desired

    Company Overview

    About Us

     

    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 twenty 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 1,000 professionals worldwide and offices in California, Indiana, Kansas, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, Canada, China, Singapore, Switzerland, UK and four locations in India. Visit our website at www.ipsdb.com.

     

    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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