Grand River Aseptic Manufacturing
Validation Supervisor
Grand River Aseptic Manufacturing, Grand Rapids, Michigan, us, 49528
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 Validation Supervisor will lead and coordinate qualification and validation activities at GRAM. Review and approve validation protocols, validation reports, risk assessments, procedures and technical documents. Support audits and represent Validation in client interactions. This position leads validation projects of broad scope and has either Validation staff and/or contractor reports.
Non-Negotiable Requirements:Completion of a bachelor's degree in Life Sciences or related field is required.A minimum of 8 years' related work experience in a pharma, biopharma, and/or biotech manufacturing environment.Demonstrated project management and leadership skills.Knowledge of relevant PDA guidance and ISPE Baseline Guides for Commissioning and Qualification.Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations.Must have proficient computer skills in Microsoft Word, Excel and Outlook.Preferred Requirements:
Experience in an aseptic environment preferred.Responsibilities Include (but are not limited to):
Maintain and provide oversight of the execution for programs covering equipment and processes related to sterility assurance.Utilize risk assessment to identify critical areas for validation and determine testing approach.Review change control documents, work orders, and document change requests to assess impact on validated systems.Lead validation projects of broad scope and provide direction for contractors and validation staff supporting those projects.Work cross functionally to establish project schedules.Manage resolution of protocol deviations and non-conformances related to Validation projects.Train Validation staff.Ensure that reports meet department and company metrics.Proactively and regularly communicate with the project team to update on validation status.Identify process improvement opportunities and equipment needs for manufacturing and finishing operations.Establish and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.Demonstrate superior project management skills and leadership qualities.Support sterility assurance specific deviation investigations and implement CAPA based on validation changes.
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.If you meet the required criteria listed above, GRAM welcomes you to apply today!
. 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 Validation Supervisor will lead and coordinate qualification and validation activities at GRAM. Review and approve validation protocols, validation reports, risk assessments, procedures and technical documents. Support audits and represent Validation in client interactions. This position leads validation projects of broad scope and has either Validation staff and/or contractor reports.
Non-Negotiable Requirements:Completion of a bachelor's degree in Life Sciences or related field is required.A minimum of 8 years' related work experience in a pharma, biopharma, and/or biotech manufacturing environment.Demonstrated project management and leadership skills.Knowledge of relevant PDA guidance and ISPE Baseline Guides for Commissioning and Qualification.Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations.Must have proficient computer skills in Microsoft Word, Excel and Outlook.Preferred Requirements:
Experience in an aseptic environment preferred.Responsibilities Include (but are not limited to):
Maintain and provide oversight of the execution for programs covering equipment and processes related to sterility assurance.Utilize risk assessment to identify critical areas for validation and determine testing approach.Review change control documents, work orders, and document change requests to assess impact on validated systems.Lead validation projects of broad scope and provide direction for contractors and validation staff supporting those projects.Work cross functionally to establish project schedules.Manage resolution of protocol deviations and non-conformances related to Validation projects.Train Validation staff.Ensure that reports meet department and company metrics.Proactively and regularly communicate with the project team to update on validation status.Identify process improvement opportunities and equipment needs for manufacturing and finishing operations.Establish and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.Demonstrate superior project management skills and leadership qualities.Support sterility assurance specific deviation investigations and implement CAPA based on validation changes.
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.If you meet the required criteria listed above, GRAM welcomes you to apply today!