See more Collapse

Validation Engineer/Specialist

1 month ago

Mill Hall, 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/Specialist to join our talented team.

In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. Additionally, you will follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. You 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 needed.
  • 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 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 needed.

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

Qualifications & Requirements:
  • Associates or Bachelor degree in related field preferred
  • 2 or more years of relevant experience.
  • Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
  • Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.

Preferred Qualifications

  • 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 & Safety

  • This position will have up to 100% travel to the site, or as required by the assigned project.
  • You may be assigned to a client site for an extended period.
  • Overnight travel or staying in the city of the Clients 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

We have other current jobs related to this field that you can find below

  • Validation Engineer/Specialist

    2 weeks ago

    Mill Hall, Pennsylvania, 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/Specialist to join our talented team. In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation,...

  • Research Specialist

    1 week ago

    Mill Hall, United States Avery Dennison Full time

    **Company Description** At Avery Dennison, some of the great benefits we provide are: - Health & Wellness benefits starting on day 1 of employment - Paid parental leave - 401K eligibility - Tuition reimbursement - Flexible work arrangements - Employee Assistance Program eligibility / Health Advocate - Paid vacation and Paid holidays Avery Dennison is...

  • Senior Quality Engineer

    2 weeks ago

    Pine Hall, United States Wieland Full time

    Job DescriptionJob DescriptionWieland is hiring a Sr. Quality Engineer. The Quality Engineer will be responsible for Developing, evaluating, and improving methods for complex manufacturing processes related to part fabrication of copper tubing. Apply knowledge of products, processes, production methods, equipment capabilities, problem solving tools, and...

  • Direct Support Professional

    1 month ago

    Mill Hall, Pennsylvania, United States Community Services Group (CSG) Full time

    Currently hiring for positions in Avis, Jersey Shore, Lock Haven and Woolrich, PA.It's fun to work in a company where people truly BELIEVE in what they're doing We're committed to bringing passion and customer focus to the business.Summary:Are you a Direct Care Worker, Personal Care Assistant, Residential Specialist, Home Health Aid, Caregiver, Certified...

  • Direct Support Professional

    2 weeks ago

    Mill Hall, Pennsylvania, United States Community Services Group (CSG) Full time

    Currently hiring for positions in Avis, Jersey Shore, Lock Haven and Woolrich, PA.It's fun to work in a company where people truly BELIEVE in what they're doing We're committed to bringing passion and customer focus to the business.Summary:Are you a Direct Care Worker, Personal Care Assistant, Residential Specialist, Home Health Aid, Caregiver, Certified...

  • Direct Support Professional

    4 weeks ago

    Mill Hall, Pennsylvania, United States Community Services Group (CSG) Full time

    Currently hiring for positions in Avis, Jersey Shore, Lock Haven and Woolrich, PA.It's fun to work in a company where people truly BELIEVE in what they're doing We're committed to bringing passion and customer focus to the business.Summary:Are you a Direct Care Worker, Personal Care Assistant, Residential Specialist, Home Health Aid, Caregiver, Certified...

  • Civil Engineer

    2 months ago

    Fort Mill, United States R. Joe Harris & Associates, Inc. Full time

    🌟 Calling all Civil Engineers with a Passion for Land Development! 🌟Are you ready to make your mark in the dynamic world of land development? Join our team at R. Joe Harris & Associates and be part of shaping the communities of tomorrow!As a Civil Engineer specializing in land development, you'll play a pivotal role in bringing innovative projects to...

  • Civil Engineer

    4 weeks ago

    Fort Mill, United States R. Joe Harris & Associates, Inc. Full time

    🌟 Calling all Civil Engineers with a Passion for Land Development! 🌟Are you ready to make your mark in the dynamic world of land development? Join our team at R. Joe Harris & Associates and be part of shaping the communities of tomorrow!As a Civil Engineer specializing in land development, you'll play a pivotal role in bringing innovative projects to...

  • Continuous Improvement Engineer

    1 month ago

    Fort Mill, United States Samuel Son & Co. Full time

    Job DescriptionPOSITION SUMMARY The Continuous Improvement Specialist will be responsible for supporting and assisting the Continuous Improvement Manager in the organization, planning, implementation and follow-through of continuous improvement initiatives. The Continuous Improvement Specialist is an expert in continuous improvement processes who teaches...

  • Continuous Improvement Engineer

    4 weeks ago

    Fort Mill, United States Samuel Son & Co. Full time

    Job DescriptionPOSITION SUMMARY The Continuous Improvement Specialist will be responsible for supporting and assisting the Continuous Improvement Manager in the organization, planning, implementation and follow-through of continuous improvement initiatives. The Continuous Improvement Specialist is an expert in continuous improvement processes who teaches...

  • Technical Specialist

    1 month ago

    White Hall, United States Zoetis Full time

    States considered: Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. At Zoetis, we manufacture high quality medicines for dogs, cats, and livestock. Looking for your chance to work for the #1 Animal Health company in the world? Zoetis is looking for the next amazing colleague to join the family. Benefits Include: Great Health...

  • Technical Specialist

    4 weeks ago

    White Hall, United States Zoetis Full time

    States considered: Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. At Zoetis, we manufacture high quality medicines for dogs, cats, and livestock. Looking for your chance to work for the #1 Animal Health company in the world? Zoetis is looking for the next amazing colleague to join the family. Benefits Include: Great Health...

  • Technical Specialist

    3 weeks ago

    White Hall, United States Zoetis Full time

    States considered: Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. At Zoetis, we manufacture high quality medicines for dogs, cats, and livestock. Looking for your chance to work for the #1 Animal Health company in the world? Zoetis is looking for the next amazing colleague to join the family. Benefits Include: Great Health...

  • Technical Specialist

    4 weeks ago

    White Hall, United States Zoetis Full time

    States considered: Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. At Zoetis, we manufacture high quality medicines for dogs, cats, and livestock. Looking for your chance to work for the #1 Animal Health company in the world? Zoetis is looking for the next amazing colleague to join the family. Benefits Include: Great Health...

  • Community Living Specialist

    2 weeks ago

    Windsor Mill, United States NATIONAL CENTER ON INSTITUTIONS AND Full time

    Community Living Specialist Position at National Center on Institutions and Alternatives IncLocation: Baltimore, MD Type of Position: Full Time Shift: Evening Overview: Join our team as a Community Living Specialist at the National Center on Institutions and Alternatives Inc. In this role, you will play a vital part in providing care, training, support, and...

  • Process Engineer

    4 weeks ago

    Fort Mill, United States Samuel Son & Co. Full time

    Job DescriptionHere are some of the great benefits that we offer: Company paid health and dental benefits. Paid vacation and an annual bonus 401k Plan with company match Opportunity for career stability and growth Tuition reimbursement program Flexibility with start and end times (depending on circumstances and position) Protective personal equipment is...

  • Design Engineer 1

    2 weeks ago

    Windsor Mill, United States Xcellas360 Full time

    Job DescriptionJob DescriptionAre you looking for a great company to work in and be a value add to the company and yourself? Are you looking for a company that has years of engineering experience with their leadership team that is eager to share their knowledge with you?Are you someone who strives to achieve success?Are you someone that is willing to...

  • Design Engineer 1

    6 days ago

    Windsor Mill, United States Xcellas360 Full time

    Job DescriptionJob DescriptionAre you looking for a great company to work in and be a value add to the company and yourself? Are you looking for a company that has years of engineering experience with their leadership team that is eager to share their knowledge with you?Are you someone who strives to achieve success?Are you someone that is willing to...

  • Design Engineer 1 Utility

    2 weeks ago

    Windsor Mill, United States Xcellas360 Full time

    Job Description Job Description Are you looking for a great company to work in and be a value add to the company and yourself? Are you looking for a company that has years of engineering experience with their leadership team that is eager to share their knowledge with you? Are you someone who strives to achieve success? Are you someone that is willing to...

  • Application Engineer

    1 month ago

    Fort Mill, United States ittxylem Full time

    Job Details We're Hiring for an Application Engineer! If you are excited and passionate about helping #LetsSolveWater, consider joining our team today! Xylem, Inc. is a leading global water technology company servicing more than 150 countries and is dedicated to solving the world's most challenging water issues.We are looking for individuals to join our...