Talent.com
Process Validation Engineer or Specialist II
Process Validation Engineer or Specialist IIGrand River Aseptic Manufacturing • Grand Rapids, MI, US
No longer accepting applications
Process Validation Engineer or Specialist II

Process Validation Engineer or Specialist II

Grand River Aseptic Manufacturing • Grand Rapids, MI, US
10 days ago
Job type
  • Full-time
Job description

Overview of this Position :

The Validation Engineer or Specialist II supports validation of cGMP equipment, facilities, and processes. These duties will include but are not limited to : validation of laboratory systems, production equipment, manufacturing processes and utilities.

Non-Negotiable Requirements :

  • Completion of a bachelor's degree in Engineering is required for the Engineer role. Completion of a bachelor's degree in life sciences or other related field is required for the Specialist role.
  • A minimum of 3 years' related work experience in a pharma, biopharma, and / or biotech manufacturing environment.
  • Proficient computer skills in Microsoft Word, Excel, and Outlook.
  • Demonstrated project management and leadership skills.
  • Must be open to working in a 24 / 7 manufacturing environment.

Preferred Requirements :

  • Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations.
  • Knowledge of GAMP5, ISPE Baseline Guides for Commissioning and Qualification, Annex 1 and FDA process validation guidance preferred.
  • Responsibilities Include (but are not limited to) :

  • Assist with maintaining and revising validation procedures.
  • Establish and maintain good practices with regards to processes and / or internal conditions leading to an aseptic environment.
  • Establish and execute programs covering equipment, processes, cleaning, process, and computer system validation.
  • Assure that all validation is performed to conform to GRAM's and cGMP requirements.
  • Provide validation support to internal customers such as Technical Services, Quality Control, Manufacturing, and other users of validation services.
  • Write, review, and execute protocols.
  • Write, review, and execute studies for process improvement and scale up projects.
  • Provide technical support to Manufacturing - troubleshooting and resolving process related issues.
  • Proactively and regularly communicate with the project team to update on validation status.
  • Identify process improvement opportunities and equipment needs for manufacturing / packaging.
  • Develop and execute Deviations and CAPA based on validation changes.
  • Review and approve forms associated with facility and equipment calibration, maintenance, etc.
  • Maintains equipment logbooks and other forms to document use, proper cleaning, and sterilization.
  • Support Agency, customer, and vendor audits as needed.
  • Full job description available during formal interview process.

    What Sets GRAM Apart from Other Employers :

    MEDICAL BENEFITS starting day 1 : Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying on average 75% of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

    Paid VOLUNTEERISM starting day 1 : GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

    PTO : Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

    WELLNESS TIME OFF : Employees earn 1 hour of time off for every 30 hours worked to use how you choose.

    PAID HOLIDAYS : We offer 10 paid holidays per calendar year with immediate eligibility!

    PAY : Depends on Experience and is discussed during the interview process.

    If you meet the required criteria listed above, GRAM welcomes you to apply today!

    J-18808-Ljbffr

    Create a job alert for this search

    Validation Engineer • Grand Rapids, MI, US

    Related jobs
    Test & Validation Technician - 1st Shift

    Test & Validation Technician - 1st Shift

    LG Energy Solution Michigan, Inc. • Holland, MI, US
    Full-time
    Test & Validation Technician.Medical, Dental and Vision benefits are paid 100% by LG Energy Solution!.LG Energy Solution Michigan Inc. LGESMI) develops and manufactures large lithium ion polymer...Show more
    Last updated: 9 days ago • Promoted
    Systems Technician

    Systems Technician

    The Viking Group • Hastings, MI, US
    Full-time
    Be Part of Something That Matters.At Viking, we're not just building fire protection equipment - we're building peace of mind. Our products help protect lives and property around the world, ...Show more
    Last updated: 30+ days ago • Promoted
    Maintenance Tech - Wayland / 2nd shift

    Maintenance Tech - Wayland / 2nd shift

    Mayville Engineering Company, Inc. • Wayland, MI, United States
    Full-time
    Maintenance Tech - Wayland / 2nd shift.Our growing company is seeking to hire a.An overview includes routine and emergency mechanical and electrical maintenance on all machines and equipment, diagnos...Show more
    Last updated: 30+ days ago • Promoted
    Process Engineer

    Process Engineer

    Clarion Technologies • Greenville, MI, US
    Full-time
    Manufacturing support position with responsibilities focused upon the development and optimization of new products and processes. Perform all 1st shot samples at the manufacturing plant and buy off / ...Show more
    Last updated: 25 days ago • Promoted
    Process Engineer - #2519.14

    Process Engineer - #2519.14

    Wade Trim • Grand Rapids, MI, US
    Full-time
    Our excellent salary and benefits package includes medical, dental, vision, life insurance, short and long-term disability coverage, education reimbursement, 401(k), performance bonuses, and an emp...Show more
    Last updated: 10 days ago • Promoted
    Behavior Technician

    Behavior Technician

    Centria Autism • Cascade, MI, US
    Full-time
    We are looking for enthusiastic individuals to join our team as Behavior Technicians.As a Behavior Technician, you will have the opportunity to make a real difference in the lives of children with ...Show more
    Last updated: 30+ days ago • Promoted
    Tig Welder

    Tig Welder

    MIDDLEVILLE ENGINEERED SOLUTIONS LLC • Middleville, MI, US
    Full-time
    Join Our Dynamic Team as a Weld Repair Technician!.At Middleville Engineered Solutions, we’re seeking a motivated and experienced Weld Repair Technician to join our growing team.In this essen...Show more
    Last updated: 4 days ago • Promoted
    Quality Manager

    Quality Manager

    Mayville Engineering Company, Inc. • Byron Center, MI, United States
    Full-time
    Byron Center / Wayland, Michigan facilities.This is an incredible opportunity to work with a world class team!.MEC's Quality Systems and team. This is a great position for a change agent who has passi...Show more
    Last updated: 6 days ago • Promoted
    1st Shift R&D Process Developer

    1st Shift R&D Process Developer

    Michigan Turkey Producers • Grand Rapids, MI, US
    Full-time
    Under the supervision of the R&D Manager, the Process Developer will support the development and continuous improvement of MTP production processes for all commodity and value-added (raw & ...Show more
    Last updated: 8 days ago • Promoted
    System Technician

    System Technician

    Viking Group • Hastings, MI, US
    Full-time
    Be Part of Something That Matters.At Viking, we're not just building fire protection equipment - we're building peace of mind. Our products help protect lives and property around the world, ...Show more
    Last updated: 30+ days ago • Promoted
    RN Float ICU / ED

    RN Float ICU / ED

    Corewell Health • Fremont, MI, United States
    Full-time
    The Gerber ED is a certified Primary Stroke Center and Level IV Trauma Center.There are over 20 care spaces to treat patients with minor to major medical and traumatic emergencies.Interdisciplinary...Show more
    Last updated: 5 hours ago • Promoted • New!
    Process Improvement Specialist

    Process Improvement Specialist

    Hope Network • Grand Rapids, MI, US
    Full-time
    Process Improvement Specialist.At Hope Network, over 2,800 compassionate professionals serve individuals across 125+ locations statewideeach playing a vital role in creating powerful comebacks.Whet...Show more
    Last updated: 22 days ago • Promoted
    Entry Level Chemical Operator

    Entry Level Chemical Operator

    Aurorium • Zeeland, MI, United States
    Full-time
    Aurorium is the materials innovation partner that helps global manufacturers harness the power of possibility to make the world a better place. Their specialty ingredients and high-performance mater...Show more
    Last updated: 30+ days ago • Promoted
    Quality Engineer

    Quality Engineer

    Jobot • Wyoming, MI, United States
    Full-time
    Propulsion Engineer - Cutting Edge Space & Defense Products!.This Jobot Job is hosted by : Stephen Brainerd.Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resum...Show more
    Last updated: 5 days ago • Promoted
    Machine Builder - III

    Machine Builder - III

    M W Watermark Llc • Holland, MI, US
    Full-time
    Job Title : Machine Builder III.Reports To : Production Supervisor.Employment Status : Full Time (40 hours per week).MW Watermark wants to make a difference. We are passionate about the world’s w...Show more
    Last updated: 22 days ago • Promoted
    Industrial Refrigeration Technician

    Industrial Refrigeration Technician

    Cargill • Howard City, MI, US
    Full-time
    New, easy-to-apply options are available for this role : chat with our recruiting assistant Ana at careers.Want to build a stronger, more sustainable future and cultivate your career? Join Cargill's...Show more
    Last updated: 11 days ago • Promoted
    Process Engineer - Technical Team

    Process Engineer - Technical Team

    fairlife • Coopersville, MI, US
    Full-time
    LLC is a Chicago-based nutrition company that creates great-tasting, nutrition-rich and dairy products to nourish consumers. With over $3B in annual retail sales, fairlife's portfolio of delicio...Show more
    Last updated: 30+ days ago • Promoted
    Process Auditor

    Process Auditor

    Boar's Head • Holland, MI, US
    Full-time
    Responsible for auditing all steps in the manufacturing processes to ensure they comply with Company specifications.Liaison with Customer Service, Plant Manager, and the Quality Assurance Manager t...Show more
    Last updated: 29 days ago • Promoted
    Sr. Manufacturing Engineer

    Sr. Manufacturing Engineer

    1013 Clarios APS Production, LLC. • Holland, Michigan, United States
    Full-time
    As a Manufacturing Engineer specializing in automation, you will lead the design, implementation, and optimization of automated systems across our production lines. Your work will directly impact eq...Show more
    Last updated: 26 days ago • Promoted
    Production Operator - 2nd Shift / Byron Center

    Production Operator - 2nd Shift / Byron Center

    Mayville Engineering Company, Inc. • Byron Center, MI, United States
    Full-time
    Production Operator - 2nd Shift / Byron Center.Our growing company is seeking to hire : .Shift Production Operators (Robotic Welders). What Does It Take to Be a Fit for working at Mayville Engineering C...Show more
    Last updated: 30+ days ago • Promoted