- 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.
- Associate or bachelor's degree in related field preferred.
- 2 or more years of relevant experience.
- Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
- Proficiency with Microsoft Office Suite.
- 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.
- Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
- 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 of time.
- 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 will visit Client sites and will be required to adhere to stated safety rules.
-
Validation Engineer
2 weeks ago
Sun Pharmaceutical Industries New Brunswick, United StatesJob Title: Validation Engineer - Pharmaceutical · Job Summary: · The Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements ...
-
Validation Engineer
2 days ago
Sun Pharmaceutical Industries New Brunswick, United StatesJob Title: Validation Engineer - Pharmaceutical · Job Summary: · The Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements ...
-
Validation Engineer
2 weeks ago
Kashiv BioSciences LLC Piscataway, United StatesKey Duties & Responsibilities · Draft and implement Quality System documentation including SOPs and Traceability Matrix designed to establish good validation practices within the organization. · Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guideline ...
-
Facility Validation Engineer
2 weeks ago
Kaztronix New Brunswick, United StatesFacilities Validation Engineer · No C2C or sponsorship · The Validation Engineer is responsible for completing assigned equipment validation, packaging validation, computers validation, cleaning validation, and process areas to meet cGMP requirements. · Job Function: · Prepa ...
-
Facility Validation Engineer
2 weeks ago
Kaztronix New Brunswick, United StatesFacilities Validation Engineer · The Validation Engineer is responsible for completing assigned equipment validation, packaging validation, computers validation, cleaning validation, and process areas to meet cGMP requirements. · Job Function: Prepare and execute IQ / OQ / PQ p ...
-
Facility Validation Engineer
1 week ago
Kaztronix New Brunswick, United StatesFacilities Validation Engineer · No C2C or sponsorship · The Validation Engineer is responsible for completing assigned equipment validation, packaging validation, computers validation, cleaning validation, and process areas to meet cGMP requirements. · Job Function: · Prepare ...
-
Validation Specialist
2 weeks ago
Katalyst Healthcares and Life Sciences South Plainfield, United StatesResponsibilitiesPerforms validation document generation, program management, and protocol execution activities. · Interface with Engineering, and end user groups to support development of life cycle documents and system requirements. · Design the validation approach with techni ...
-
Computer Systems Validation Specialist
2 weeks ago
LabVantage Somerset, United StatesA.Job Description ObjectiveLabVantage Professional Services (PSO) are expanding their team to provide an increased level of Computer Systems Validation (CSV) services and solutions, to address growing customer needs. As a key member of the LabVantage PSO team, the LIMS CSV Specia ...
-
Product Validation Engineering Technician
4 days ago
Cummins New York, United States**Product Validation Engineering Technician 1st Shift** · **Pay Range $30.46- $45.69** · Our culture believes in _POWERING YOUR POTENTIAL_. We provide global opportunities to develop your career, make your community a better place and work with today's most innovative thinkers to ...
-
Product Validation Engineering Technician
1 week ago
Cummins New York, United States**Product Validation Engineering Technician · - 1st Shift** · **Pay Range $30.46- $45.69** · Our culture believes in _POWERING YOUR POTENTIAL_. We provide global opportunities to develop your career, make your community a better place and work with today's most innovative thinker ...
-
Validation - Validation Specialist
2 weeks ago
HonorVet Technologies Trenton, United StatesJob Description: Validation Specialist · Warren, NJOnsite · Work Schedule: Mon - Fri, Business Hours · The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities ...
-
validation engineers
3 weeks ago
United Pharma Technologies Inc South Plainfield, United StatesVALIDATION ENGINEERS - United Pharma Technologies, Inc. - South Plainfield, NJ So. Plainfield, NJ & other unantcptd locns nationwide. Duties: Analyze validation test data to determine whether systems or processes have met validation criteria & to identify root causes of problems ...
-
Validation - Validation Specialist
1 week ago
TechDigital Corporation Trenton, United StatesSenior Validation Specialist · Warren, NJ--Onsite · Work Schedule: Mon - Fri, Business Hours · The Senior Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities ...
-
Validation - Validation Specialist
1 week ago
TechDigital Corporation Trenton, United StatesSenior Validation SpecialistWarren, NJ--OnsiteWork Schedule: Mon - Fri, Business HoursThe Senior Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qu ...
-
Validation - Validation Specialist
2 weeks ago
HonorVet Technologies Trenton, United StatesJob Description: Validation SpecialistWarren, NJOnsiteWork Schedule: Mon - Fri, Business HoursThe Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: q ...
-
validation engineers
2 weeks ago
UNITED CONSULTING HUB, INC. Metuchen, United StatesVALIDATION ENGINEERS - UNITED CONSULTING HUB, INC. - METUCHEN, NJ Metuchen, NJ & other unantcpt'd locns nationwide. Duties: Analyze validation test data to determine whether systems or processes have met validation criteria & to identify root causes of problems for various pharma ...
-
Validation Engineer/Specialist
2 weeks ago
IPS-Integrated Project Services, LLC Trenton, United StatesJob 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 · to join our talented team at our office located in · ...
-
Sr Associate, Validation Engineer
2 weeks ago
Prostaff Solutions LLC New Brunswick, United StatesAre you looking to be a part of a premier pharmaceutical company? One of our largest clients is currently seeking a Sr. Associate, Validation Engineer to join their New Brunswick, New Jersey team. Our client is one of the leading pharmaceutical companies specializing in developin ...
-
Validation Engineer II
3 weeks ago
Amneal Pharmaceuticals Piscataway, United States: · The Validation Engineer II is responsible for performing validation and Engineering activities, conducting development studies, analyzation and assist in improving pharmaceutical systems and processes. · Essential Functions: · + Design, review and execute validation docume ...
-
Sr Associate, Validation Engineer
1 week ago
Prostaff Solutions LLC New Brunswick, United StatesAre you looking to be a part of a premier pharmaceutical company? One of our largest clients is currently seeking a · Sr. Associate, Validation Engineer · to join their · New Brunswick, New Jersey team . Our client is one of the leading pharmaceutical companies specializing in ...
Validation Engineer/Specialist - Somerset, United States - IPS-Integrated Project Services, LLC
Description
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 at our office located in Somerset, New Jersey.
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. You will also follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements.
What You'll Do
Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights
Qualifications & Requirements:Preferred Qualifications
Context, Environment, & Safety
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.
