Jobs
>
New York City

    Senior Validation Engineer - New York, United States - CAI

    CAI
    CAI New York, United States

    1 week ago

    Default job background
    Description

    Position Description:
    The CQV Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are responsible for protocol writing and execution (field verification), and development of summary reports at client sites. Other responsibilities include planning / coordinating work and directing small teams in document development and / or execution.

    Requirements include:


    Position Requirements:
    BS in a science or engineering field or equivalent years of experience

    4-8 years' experience in commissioning and qualification in a regulated industry

    Ideally experienced in 1 or more of the following: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation or other pharmaceutical manufacturing processes

    Excellent technical problem-solving and troubleshooting skills

    High attention to detail

    Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines

    Ability to work independently, while supporting other team members

    Expertise in Microsoft Word and Excel

    Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus.


    Other Requirements:
    Excellent oral and written communication skills in English

    Able to travel domestically and internationally as required

    Able to work (paid) overtime

    Able to work in the US without sponsorship now or any time in the future.

    About CAI

    CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide.

    We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.

    Meeting a Higher Standard


    Our approach is simple; we put the client's interests first, we do not stop until it is right, and we will do whatever it takes to get there.

    As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:

    We act with integrity.

    We serve each other.

    We serve society.

    We work for our future.

    With employee ownership, one person's success is everyone's success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.

    Benefits


    Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.

    #LI-MV1

    $87,100 - $94,600 a year

    Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.


    We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace.

    Diversity is a strength for our global company.

    We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society.

    This job description is not all inclusive and you may be asked to do other duties.

    CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).

  • eTeam

    Validation Engineer

    1 week ago

    eTeam New York, United States

    Job Title: Validation Engineer · Location: Athens, GA · Duration: 06 months · Duties: · Perform Smoke studies and assist in semi-annual Media fill qualifications as a SME Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers and ware ...

  • Ascendum KPS

    Validation Engineer

    1 week ago

    Ascendum KPS New York, United States

    Job description · Improving manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement. · Developing basic experiments and tests (including writing and executing protocols) to qualify and validate manufacturing proc ...

  • Glatt Group

    Validation Engineer

    1 week ago

    Glatt Group New York, United States

    Job description · Essential Job Function: · 1. Must have the ability to develop validation protocols (IQ and OQ), validation reports, and factory acceptance test documents. As such, good writing and grammar skills and attention to detail are essential. · 2. Experience is required ...

  • HCLTech

    Validation Engineer

    1 week ago

    HCLTech New York, United States

    Job Description : · 1) 7 to 9 years of Experience in Software verification and testing activities. · 2) Design, develop, and execute comprehensive test plans, test protocols and test cases for verification and validation of embedded software. · 3) Collaborate with cross-function ...

  • Premier Life Sciences LLC

    Validation Engineer

    4 days ago

    Premier Life Sciences LLC New York, United States

    Not For C2C Candidates Please do not apply even not enquire · Job Title: CQV Validation Engineer · Location: Countrywide USA · Contract Duration: 12+ months · Pay: Negotiable on w2 without any benefits · Responsibilities: · Authoring, editing, and executing technical commission ...

  • Aequor Inc

    Validation Engineer

    4 days ago

    Aequor Inc New York, United States

    Position: Validation Engineer · Location: Summit NJ 07901 · Duration: 6+ months (possibility of extension for the right candidate depending on performance) · Pay rate: $78.66/ hour on W2 · 100% onsite · Highly preferred cell therapy equipment commissioning qualification. · Mus ...

  • Aequor Inc

    Validation Engineer

    5 days ago

    Aequor Inc New York, United States

    Validation Engineer I/ II · Location: Athens, GA · Duration: 6+ Months with possible extension. · Duties: · Perform Smoke studies and assist in semi-annual Media fill qualifications as a SME. · Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold ...

  • Aequor Inc

    Validation Engineer

    1 week ago

    Aequor Inc New York, United States

    Job Title: Validation Engineer · Location: Athens, GA · Duration: 1 Year contract + Will be extend · Shift hours: 40 Hours in a week · Pay Range: $40-48/hr. on W2. · Job Description: · Duties: · Perform smoke studies and assist in semi annual Media fill qualifications as a SME. ...

  • Pyramid Consulting

    Validation Engineer

    4 days ago

    Pyramid Consulting New York, United States

    Immediate need for a talented · Validation Engineer - I (Assistant) . This is a · 06+ Months Contract · opportunity with long-term potential and is located in · West Point, PA(Onsite) . Please review the job description below and contact me ASAP if you are interested. · Job ...

  • Premier Life Sciences LLC

    Validation Engineer

    5 hours ago

    Premier Life Sciences LLC New York, United States

    Not For C2C Candidates Please do not apply even not enquire · Job Title: CQV Validation Engineer · Location: Countrywide USA · Contract Duration: 12+ months · Pay: Negotiable on w2 without any benefits · Responsibilities: · Authoring, editing, and executing technical commission ...

  • ALTEN Technology USA

    Validation Engineer

    5 hours ago

    ALTEN Technology USA New York, United States

    We're ALTEN Technology USA, an engineering company that provides solutions for engineering, technology, and product development projects. For decades, we've been helping our clients develop products that are changing the world, from the efficient heavy truck of tomorrow to a full ...

  • Katalyst Healthcares and Life Sciences

    Validation Engineer

    1 week ago

    Katalyst Healthcares and Life Sciences New York, United States

    Responsibilities:Review qualification requirements for any new instrument, equipment and process with system owner and cross-functional teams. · Prepare protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packagi ...

  • Novozen Healthcare LLC

    Validation Engineer

    5 days ago

    Novozen Healthcare LLC New York, United States

    What You'll Do · o Commissioning Forms · o C/Q/V Protocols and Summary Reports · o Standard Operating Procedures · o Impact Assessments · o Specifications (URS/FRS/DDS) · o FATS/SATs ·  Perform field/site activities including, but not limited to, the following: · o Attend and w ...

  • LS Solutions Inc.

    Validation Engineer

    1 day ago

    LS Solutions Inc. New Jersey, United States Full time, contract, training

    Key Responsibilities Strong Experience in Computer Systems Validation (CSV) within the pharmaceutical industry. Required Bachelor's degree in pharmaceutical Science OR related field of study. Schedule and plan equipment and process qualification workload to meet approved schedule ...

  • Katalyst Healthcares and Life Sciences

    Validation Engineer

    1 week ago

    Katalyst Healthcares and Life Sciences Jersey City, United States

    Responsibilities: Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and client's corporate principles, quality policies, standards, and core va ...

  • Yoh, A Day & Zimmermann Company

    Sr. Validation Engineer

    1 week ago

    Yoh, A Day & Zimmermann Company New York, United States

    Our client, a global bio-pharmaceutical company, that specializes in core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines, is actively looking to add a · Sr. Validation Engi ...

  • Trinity Consultants

    Clean Validation Engineer

    5 days ago

    Trinity Consultants New York, United States

    ADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufac ...

  • Technical Source

    Process Validation Engineer

    5 days ago

    Technical Source New York, United States

    Technical Source is currently in search of a · Process Validation Engineer · for our pharmaceutical manufacturing client in the Rocky Mount-Wilson, NC area. This is a long-term contract opportunity that operates on a rotating shift schedule. The ideal candidate for this positio ...

  • Akkodis

    HiL Validation Engineers

    1 week ago

    Akkodis New York, United States

    Akkodis is seeking two experienced HiL Validation Engineers for full-time roles in the Detroit Metropolitan area. Qualified candidates will possess more than three years of professional experience in hardware-in-loop testing (bench) accompanied by Python and/or CAPL scripting for ...

  • BioPhase

    Senior Validation Engineer

    1 week ago

    BioPhase New York, United States

    *US Citizens or Greencard Holders only* · **No C2C** · Work Schedule: · Onsite - M-F · Salary: · $60-70/hr · Duration: · 4 months · Primary Responsibilities: · Support the Quality Engineering group with documentation and validation needs. · Draft URS documents, design specif ...