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Validation - Validation Specialist
2 days 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 ...
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Validation - Validation Specialist
6 days 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 ...
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Validation - Validation Specialist
1 week 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 ...
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Validation - Validation Specialist
2 days 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 ...
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Validation Specialist
4 days ago
Primary Talent Partners Inc. Trenton, United StatesPrimary Talent Partners has a 6-month contract opening for a Validation Specialist with one of our pharmaceutical clients in Warren, NJ.Job Title: Validation SpecialistPay: $ $61.50/hourLocation: 100% Onsite in Warren, NJ - local candidates onlyTerm: 6-month contract (possibility ...
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Validation Specialist
5 days ago
Pyramid Consulting Trenton, United StatesImmediate need for a talented Validation Specialist . This is a 06+ Months Contract opportunity with long-term potential and is located in Warren, NJ(Onsite) . Please review the job description below and contact me ASAP if you are interested.Job ID: Pay Range: $55 - $62/hour. Emp ...
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Validation Specialist
1 week ago
Rangam Trenton, United StatesPay Scale: $60.00 -$63.00 per Hourly · Job Description: · 100% Onsite in Warren, NJ · Lab w/o blood & animal · Duties: · The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. · Prim ...
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Validation Specialist
1 week ago
Primary Talent Partners, Inc. Trenton, United StatesPrimary Talent Partners has a 6-month contract opening for a Validation Specialist with one of our pharmaceutical clients in Warren, NJ. · Job Title: Validation Specialist · Pay: $ $61.50/hour · Location: 100% Onsite in Warren, NJ - local candidates only · Term: 6-month contr ...
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Validation Specialist
1 week ago
PharmaLex Trenton, United StatesJOIN OUR TEAM · PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing excitin ...
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Validation Specialist
1 day ago
Knewin Trenton, United StatesJob Description: Validation SpecialistWarren, NJ--OnsiteWork 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: ...
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Validation Specialist
2 days ago
Knewin Trenton, United StatesJob Description: Validation Specialist · Warren, NJ--Onsite · 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 responsibilitie ...
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Validation Specialist
3 days ago
Synkriom Trenton, United StatesJob Description Job Description The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory instruments, setup of computers and ...
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Validation Specialist
1 week ago
Joulé Trenton, United StatesJob Title: Validation SpecialistLocation: Warren, NJHours/Schedule: Mon - Fri, Business HoursType: Contract · Responsibilities · Performs validation document generation, program management, and protocol execution activities.Interface with Engineering, and end user groups to sup ...
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Validation Specialist
6 days ago
Joule Trenton, United StatesJob Title: Validation SpecialistLocation: Warren, NJHours/Schedule: Mon - Fri, Business HoursType: ContractResponsibilitiesPerforms validation document generation, program management, and protocol execution activities.Interface with Engineering, and end user groups to support dev ...
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Validation Specialist
9 hours ago
System One Holdings, LLC Trenton, United StatesJob Title : Validation Specialist · Location : Warren, NJ · Hours/Schedule : Mon - Fri, Business Hours · Type: · Contract · Responsibilities · Performs validation document generation, program management, and protocol execution activities. · Interface with Engineering, and en ...
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Validation Specialist
1 week ago
Pyramid Consulting Trenton, United StatesImmediate need for a talented · Validation Specialist . This is a · 06+ Months Contract · opportunity with long-term potential and is located in · Warren, NJ(Onsite) . Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay Range: ...
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Validation Specialist
2 days ago
System One Trenton, United StatesHours/Schedule: Mon - Fri, Business HoursType: ContractResponsibilitiesPerforms 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 requirem ...
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Validation Specialist
3 days ago
System One Trenton, United StatesHours/Schedule: Mon - Fri, Business Hours · Type: Contract · Responsibilities · Performs validation document generation, program management, and protocol execution activities. · Interface with Engineering, and end user groups to support development of life cycle documents and sys ...
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Validation Specialist
2 weeks ago
LanceSoft Trenton, United StatesJob Description: Commissioning/Qualification Specialist/Validation · 100% Onsite Warren, NJLocal candidates only · Work Schedule: Mon - Fri, Business Hours · Purpose and Scope: · This role supports the successful operation of facilities, laboratories, and business functions at m ...
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Senior Validation Engineer/ Specialist
1 week 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 · Senior Validation Engineer · to join our talented team at our office located ...
Validation Engineer/Specialist - Trenton, 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.
Validation Engineer
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 DoWrite 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 heightsQualifications & Requirements:
Bachelor of Science in Engineering.
2+ years of relevant experience.
Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
Proficiency with Microsoft Office Suite.
Preferred Qualifications
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.
Context, Environment, & SafetyThis 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.
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.
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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