Sr. Validation Engineer or Specialist

3 weeks ago

Grand Rapids, United States Grand River Aseptic Manufacturing Full time

Description

Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day.

Overview of this Position:

The Sr. Validation Engineer supports validation of cGMP equipment, facilities and processes. These duties will include validation of laboratory systems, production equipment, manufacturing processes, and utilities. This position will focus on in process validation.

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 5 years related work experience in a pharma, biopharma, and/or biotech manufacturing environment.
  • Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations.
  • 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 GAMP5, ISPE Baseline Guides for Commissioning and Qualification, and Annex 1 and FDA process validation guidance preferred.

Responsibilities Include (but are not limited to):

  • Coordinate and oversee process validation activities (PPQ).
  • Prepare appropriate documentation for assigned projects in the areas of equipment, software, process, control system and critical system C & Q and validation activities.
  • Conduct validation studies.
  • Utilize risk assessment to identify critical areas for validation and generate test scripts accordingly.
  • Write, review and approve validation protocols/reports, change control documents, work orders, non-conformance reports, and document change requests.
  • Proactively and regularly communicate with the project team to update on validation status.
  • Identify process improvement opportunities and equipment needs for manufacturing/packaging.
  • Establish and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.
  • 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 for 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 17 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: We offer all employees one (1) paid day of Wellness Time Off (WTO) per quarter to invest in self-care, take some downtime, or whatever 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. Shift differential available for second and third shift

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

  • System Verification and Validation Specialist

    5 days ago

    Grand Rapids, Michigan, United States Randstad Digital Full time

    We are looking for a System Verification and Validation Specialist to join our team at Randstad Digital. This role involves contributing to the development of cutting-edge systems by participating in the creation of models that define system architecture and functionality.The ideal candidate will have experience with model-based engineering, proficiency in...

  • Sr Engineer

    3 weeks ago

    Grand Rapids, United States Procyon TS Full time

    About Us: At Tech Mahindra (Tech Mahindra | Connected World, Connected Experiences), we live the philosophy of connected world and connected experiences. We thrive on change that is powered by the intelligent symphony of technology and humans designing meaningful and sustainable experiences. Consumer 'experiences' are driving and disrupting industries like...

  • Sr Engineering Project Manager

    6 days ago

    Grand Rapids, United States Diverse Lynx Full time

    Role-Sr Engineering Project ManagerLocation- Grand Rapids, MI (Onsite / Hybrid)Job Type- Fulltime HiringEngineering Project Manager with Avionics / Aerospace experienceJD: The Engineering Project Manager holds responsibility for overseeing every facet of engineering project execution throughout the development stage of the program lifecycle This encompasses...

  • Sr. Manager, Systems Engineering-Avionics Aftermarket Engineering

    6 days ago

    Grand Rapids, United States L3Harris Technologies Full time

    Job Title: Sr. Manager, Systems Engineering-Avionics Aftermarket Engineering Leader Job Code: 18813 Job Location: Phoenix, AZ- Grand Rapids, MI or St. Petersburg, FL Schedule: 9/80 reg with every other Friday off Job Description: L3Harris Commercial Aviation Solutions is seeking an experienced and dynamic leader to head our Aftermarket Engineering...

  • Sr. Manager, Systems Engineering-Avionics Aftermarket Engineering

    2 weeks ago

    Grand Rapids, United States L3Harris Technologies Full time

    Job Title:Sr. Manager, Systems Engineering-Avionics Aftermarket Engineering Leader Job Code: 18813 Job Location:Phoenix, AZ- Grand Rapids, MI or St. Petersburg, FL Schedule: 9/80 reg with every other Friday offJob Description: L3Harris Commercial Aviation Solutions is seeking an experienced and dynamic leader to head our Aftermarket Engineering...

  • Sr. Manager, Systems Engineering-Avionics Aftermarket Engineering

    3 weeks ago

    Grand Rapids, United States L3Harris Technologies Full time

     Job Title:  Sr. Manager, Systems Engineering-Avionics Aftermarket Engineering LeaderJob Code: 18813Job Location: Phoenix, AZ- Grand Rapids, MI or St. Petersburg, FLSchedule: 9/80 reg with every other Friday off  Job Description: L3Harris Commercial Aviation Solutions is seeking an experienced and dynamic leader to head our Aftermarket Engineering...

  • Sr. Manager, Systems Engineering-Avionics Aftermarket Engineering

    1 week ago

    Grand Rapids, United States L3Harris Technologies Full time

     Job Title:  Sr. Manager, Systems Engineering-Avionics Aftermarket Engineering LeaderJob Code: 18813Job Location: Phoenix, AZ- Grand Rapids, MI or St. Petersburg, FLSchedule: 9/80 reg with every other Friday off  Job Description: L3Harris Commercial Aviation Solutions is seeking an experienced and dynamic leader to head our Aftermarket Engineering...

  • Sr. Associate, Electrical Engineering-Avionics

    1 month ago

    Grand Rapids, United States L3 Technologies Full time

    Job Title: Sr. Associate, Electrical Engineering-Avionics Job Code: 15730 Job Location: Grand Rapids MI or St Petersburg FL (relocation available for those that qualify) Schedule: 9/80 reg (every other Friday off) Job Description: As an avionics electrical engineer, you are focused on designing and documenting electrical circuit card assemblies. The...

  • Sr. Associate, Electrical Engineering-Avionics

    5 days ago

    Grand Rapids, United States L3Harris Full time

    Job Title: Sr. Associate, Electrical Engineering-Avionics Job Code: 15730 Job Location: Grand Rapids MI or St Petersburg FL (relocation available for those that qualify) Schedule: 9/80 reg (every other Friday off) Job Description: As an avionics electrical engineer, you are focused on designing and documenting electrical circuit card assemblies. The...

  • Sr. Associate, Electrical Engineering-Avionics

    2 weeks ago

    Grand Rapids, United States L3Harris Technologies Full time

     Job Title: Sr. Associate, Electrical Engineering-AvionicsJob Code: 15730Job Location: Grand Rapids MI or St Petersburg FL (relocation available for those that qualify)Schedule: 9/80 reg (every other Friday off) Job Description: As an avionics electrical engineer, you are focused on designing and documenting electrical circuit card assemblies. The...

  • Sr. Associate, Electrical Engineering-Avionics

    3 weeks ago

    Grand Rapids, United States L3Harris Technologies Full time

     Job Title: Sr. Associate, Electrical Engineering-AvionicsJob Code: 15730Job Location: Grand Rapids MI or St Petersburg FL (relocation available for those that qualify)Schedule: 9/80 reg (every other Friday off) Job Description: As an avionics electrical engineer, you are focused on designing and documenting electrical circuit card assemblies. The...

  • Sr Packaging Engineer

    2 months ago

    Grand Rapids, United States LanceSoft Full time

    JOB DESCRIPTION Top 3 technical skills that you are required for this role: Experience in medical device packaging systems and packaging process validations IQ/OQ/PQ Advanced understanding of packaging requirements and standards I.E. ISO 11607-1 and 11607-2, ISO 13485 Experience in CAPA, support, develop and execute remediation plans Education Required:...

  • Sr. Engineer

    3 weeks ago

    Grand Rapids, United States Procyon TS Full time

    About Us: At Tech Mahindra (Tech Mahindra | Connected World, Connected Experiences), we live the philosophy of connected world and connected experiences. We thrive on change that is powered by the intelligent symphony of technology and humans designing meaningful and sustainable experiences. Consumer 'experiences' are driving and disrupting industries like...

  • Sr. Hosting Engineer

    5 days ago

    Grand Rapids, United States Dematic Full time

    We are seeking an experienced Sr. Hosting Engineer to join our global cloud team. In this role, you will be responsible for maintaining cloud-based platforms and solutions for our clients. At KION, you will be operating in a cloud-first multi-cloud environment. You can expect exciting tasks with a strong focus on automation to unlock the full potential of...

  • Sr. Civil Engineer

    4 weeks ago

    Cedar Rapids, United States Disability Solutions Full time

    ACHIEVE MORE WITH VOLT Volt is immediately hiring for a Sr. Civil Engineer in Cedar Rapids, IA. As a Sr. Civil Engineer, you will work on diverse engineering projects. Our client is a fast-growing Midwest engineering environmental firm looking for a motivated Civil Engineer, who is eager to learn and work on everything from municipal engineering to...

  • Sr Manufacturing Engineer

    7 days ago

    Grand Rapids, United States LanceSoft Full time

    JOB DESCRIPTION Top 3 technical skills that you are required for the role: Medical device experience preferred Proven problem solving background Familiar with lean principals and troubleshooting equipment Education Required: Bachelors in Engineering Field Years' Experience Required: Minimum 4 years experience Will the contractor be working 40 hours a week?...

  • Sr. Civil Engineer

    2 months ago

    Cedar Rapids, United States Volt Workforce Solution Full time

    Job DescriptionJob DescriptionACHIEVE MORE WITH VOLT Volt is immediately hiring for a Sr. Civil Engineer in Cedar Rapids, IA. As a Sr. Civil Engineer, you will work on diverse engineering projects.  Our client is a fast-growing Midwest engineering environmental firm looking for a motivated Civil Engineer, who is eager to learn and work on everything from...

  • Sr. Civil Engineer

    1 month ago

    Cedar Rapids, United States Disability Solutions Full time

    ACHIEVE MORE WITH VOLT Volt is immediately hiring for a Sr. Civil Engineer in Cedar Rapids, IA. As a Sr. Civil Engineer, you will work on diverse engineering projects.  Our client is a fast-growing Midwest engineering environmental firm looking for a motivated Civil Engineer, who is eager to learn and work on everything from municipal engineering to...

  • Automation Engineer

    2 months ago

    Grand Rapids, United States Grand River Aseptic Manufacturing Full time

    Description Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic...

  • Sr. Director, Safety

    6 days ago

    Grand Rapids, United States fairlife Full time

    Job DescriptionJob Descriptionfairlife, LLC is a Chicago-based nutrition company that creates great-tasting, nutrition-rich and dairy products to nourish consumers.With nearly $3B in annual retail sales, fairlife's portfolio of delicious, lactose-free, real dairy products includes: fairlife® ultra-filtered milk; Core Power® High Protein Shakes, a...