Jobs
>
New York City

    Validation Engineer - New York, United States - Aequor Inc

    Aequor Inc
    Aequor Inc New York, United States

    2 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    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.


    Must-Have:
    Develop validation/qualification deliverables such as Validation Plans, Requirements
    Specifications, Traceability Matrices, Summary Reports, Change Controls


    PURPOSE AND SCOPE OF POSITION:
    The Equipment Validation Engineer supports the successful implementation of various process/lab
    equipment at multi-use sites through interaction with internal customers and external service
    providers. The incumbent in this is tasked with commissioning and qualifying new equipment
    facilities, and utilities and maintaining equipment systems in a qualified/validated state according to
    established policies and procedures. The individual participates in projects and ongoing work
    activities of low to moderate complexity. With minimum supervision and given general
    instructions, this individual carries out routine tasks and functions and uses basic analytical skills
    to recognize and solve common problems of limited scope. As a developing team player, the
    incumbent interacts with their immediate supervisor and personnel within their own work group
    to achieve team goals while building trust and collaborative relationships outside the immediate
    organization.


    REQUIRED COMPETENCIES:

    Knowledge, Skills, and Abilities:

    • Knowledge of cGMP, GXP, GAMP, and SDLC regulations, including 21CFR part 11, computer
    systems validation requirements and good documentation practices.


    • Experience in the qualification of cell therapy equipment a plus
    • Advanced knowledge of pharmaceutical, manufacturing, and laboratory systems.
    • Understanding of investigations, deviations, and CAPA management in a regulated
    pharmaceutical industry.


    • Strong written and verbal communication skills.
    • Excellent interpersonal skills with experience dealing with a diverse workforce.
    • Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize
    assigned tasks in a high-paced environment and concurrently monitor tasks/assignments
    with others that may impact timely completion. Ability to effectively manage multiple tasks
    and activities simultaneously.


    • Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and
    Outlook with an extensive background in database systems. Innate ability to learn new software,
    such as corporate intranet and enterprise business.

    Education and Experience:

    • BS in Engineering or Science related discipline required
    • Minimum of 5 years experience performing/supporting activities in
    a GMP environment.


    • Minimum of 3 years experience in equipment, facility, or utility
    qualification


    DUTIES AND RESPONSIBILITIES:
    1) Maintains qualified equipment systems in compliance with policies, guidelines, and procedures:
    a. Develops qualification protocols, and associated reports while adhering to a change
    management process.
    b. Supports the execution of equipment qualifications and validation protocols.
    c. Supervises vendors for qualification functions.
    d. Develops written procedures for calibration and preventive maintenance of equipment.
    e. Supports equipment qualification and validation activities.
    f. Develop validation/qualification deliverables such as Validation Plans, Requirements
    Specifications, Traceability Matrices, Summary Reports, and Change Controls.
    2) Manages projects of limited scope and complexity within their functional area:
    a. Supports equipment implementation projects including scheduling, procurement, site prep,
    installation, qualification, and turnover to the business area.
    b. Supports internal customer groups in the procurement, operation, calibration, and
    preventive maintenance of equipment to meet business needs in accordance with required
    schedules or dates.
    c. Completes all qualification and validation documentation with accuracy, completeness and
    compliance to Celgene standards.

    3) Provides excellent customer service and support:
    a. Regularly reviews, prioritizes, and promptly responds to customer equipment qualification
    and support requests.
    b. Provides technical support and guidance on equipment qualification issues. Interfaces with
    customers to ensure all expectations are being met.
    c. Provides technical support and guidance on equipment and computer systems qualification
    and validation issues.
    d. Maintains a positive relationship with all team members and site customers while promoting
    a positive team environment.
    4) Regulatory Responsibilities
    a. Ensure equipment, facilities, and programs are maintained in compliance.
    b. May be called upon as SME in both internal and regulatory audits.


    WORKING CONDITIONS (US Only):

    Physical / Mental Demands :

    • Occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25lbs
    • Ability to sit, stand, walk, and move within the workspace for extended periods
    • Ability to perform repetitive tasks including hand-to-finger manipulations, grasping, pushing and
    pulling.


    Environmental Conditions:

    • Primarily office environment, but will be required to enter laboratory or GMP process areas
    donning proper gowning/lab coats or PPE such as safety glasses and shoes.


    • Ability to work safely and effectively when working alone, or working with others
  • Cummins

    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 thinkers to ...

  • Cummins

    Product Validation Engineering Technician

    2 weeks 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 ...

  • Cummins

    Product Validation Engineering Technician

    2 days ago

    Cummins New York, United States

    **Product Validation Engineering Technician - System Performance 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 i ...

  • eTeam

    Validation Engineer

    3 weeks 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 ...

  • Acara Solutions, An Aleron Company

    Validation Engineer

    1 week ago

    Acara Solutions, An Aleron Company New Jersey, United States

    Acara Solutions is seeking a Validation Engineer for its successful client who are a leading world supplier of integrated processing solutions for customers in the area of pharmaceuticals, food processing, feeds and fine chemicals. Our products and services stand for reliability ...

  • Glatt Group

    Validation Engineer

    3 weeks 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 ...

  • Ascendum KPS

    Validation Engineer

    3 weeks 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 ...

  • HCLTech

    Validation Engineer

    3 weeks 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 ...

  • Pyramid Consulting

    Validation Engineer

    2 weeks 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

    2 weeks 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 ...

  • Premier Life Sciences LLC

    Validation Engineer

    2 weeks 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

    2 weeks 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

    3 weeks 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. ...

  • Katalyst Healthcares and Life Sciences

    Validation Engineer

    3 weeks 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 ...

  • ALTEN Technology USA

    Validation Engineer

    2 weeks 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 ...

  • Novozen Healthcare LLC

    Validation Engineer

    2 weeks 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

    2 weeks 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

    3 weeks 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 ...

  • Technical Source

    Process Validation Engineer

    2 weeks 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 ...

  • Trinity Consultants

    Clean Validation Engineer

    2 weeks 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 ...