Process Validation Specialist

4 weeks ago

Minneapolis, United States Premier Life Sciences LLC Full time

Role: Process Validation Engineer

Duration: Long Term on W2 - **No C2C**


Required Skills and Responsibilities:

Process Validation (IQ/OQ/PQ)

  • Execute and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for sterilization processes.

Process Layout, Modelling, and Documentation

  • Design and model efficient process layouts and create comprehensive documentation for sterilization cycles and equipment.

Equipment and Tooling Development

  • Develop and implement new equipment and tooling for sterilization processes to enhance efficiency and compliance.

Process Development and Characterization

  • Innovate and optimize sterilization processes through rigorous development and characterization techniques.

Test Method Development and Validation

  • Create and validate new test methods to ensure the reliability and consistency of sterilization processes.

Developing/Updating MPIs

  • Develop and update Manufacturing Process Instructions (MPIs) to align with the latest standards and practices.

Supplier Development and Component Engineering

  • Collaborate with suppliers to enhance component quality and integrate new technologies into existing systems.

Manufacturing Engineering Support / Engineering Documentation

  • Provide ongoing support to manufacturing engineering teams and maintain accurate engineering documentation.

Update Work Instructions

  • Ensure that work instructions reflect actual practices on the production floor, maintaining alignment with procedural documentation.

Create Part Numbers for Machine Spare Parts and Supply Items

  • Generate part numbers and maintain a comprehensive inventory for machine spare parts and supply items.

Update Tooling/Fixture Drawings

  • Revise and update tooling and fixture drawings to accurately represent current production floor usage.


Experience:

  • Minimum Years of Experience Needed: 7+ years in relevant fields.

Strongly Preferred:

  • Candidates with experience in casting will be given preference due to the nature of the equipment and processes involved.


This role demands a meticulous approach to process validation, development, and documentation to ensure the highest standards of sterilization efficiency and compliance. The ideal candidate will bring a blend of technical expertise and practical experience to drive continuous improvement and innovation in our sterilization processes.

  • Process Validation Specialist

    3 weeks ago

    Minneapolis, United States Premier Life Sciences LLC Full time

    Role: Process Validation Engineer Duration: Long Term on W2 - **No C2C** Required Skills and Responsibilities: Process Validation (IQ/OQ/PQ) Execute and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for sterilization processes. Process Layout, Modelling, and Documentation Design and model...

  • Validation Engineer/Specialist II

    4 weeks ago

    Minneapolis, United States IPS-Integrated Project Services, LLC Full time

    Job Description: At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Validation Engineer II to join our talented team at our office located in Minneapolis, Minnesota. Performs cGMP compliance-based services (commissioning,...

  • Validation Engineer/Specialist II

    4 weeks ago

    Minneapolis, United States IPS - Integrated Project Services, LLC Full time

    Job Description At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Validation Engineer II to join our talented team at our office located in Minneapolis, Minnesota. Performs cGMP compliance-based services (commissioning,...

  • Validation Engineer/Specialist II

    1 month ago

    Minneapolis, Minnesota, United States IPS - Integrated Project Services, LLC Full time

    Job DescriptionAt IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Validation Engineer II to join our talented team at our office located in Minneapolis, Minnesota. Performs cGMP compliance-based services (commissioning,...

  • Validation Engineer/Specialist II

    3 weeks ago

    Minneapolis, Minnesota, United States IPS - Integrated Project Services, LLC Full time

    Job DescriptionAt IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Validation Engineer II to join our talented team at our office located in Minneapolis, Minnesota. Performs cGMP compliance-based services (commissioning,...

  • Senior Process Specialist

    3 weeks ago

    Minneapolis, Minnesota, United States Tennant Company Full time

    With more than $1B in revenue, Tennant Company is a globally recognized leader in the cleaning equipment industry. For the past 150 years, we have been passionate about developing and manufacturing innovative and sustainable solutions for our customers. At Tennant Company, we are committed to stewardship and creating a cleaner, safer and healthier world....

  • Sr Process Engineer

    4 weeks ago

    Minneapolis, United States LanceSoft Full time

    JOB DESCRIPTION HM's Top Needs: Ability to lead their own work, think critically, and communicate clearly TMV and IQ/OQ/PQ Experience Previous work leading change orders, preferably in Agile, but other systems are also acceptable. Additional detail specific to this role’s immediate responsibility below. This position will be in charge of leading the...

  • Sr Process Engineer

    2 weeks ago

    Minneapolis, United States LanceSoft Full time

    JOB DESCRIPTION HM's Top Needs: Ability to lead their own work, think critically, and communicate clearly TMV and IQ/OQ/PQ Experience Previous work leading change orders, preferably in Agile, but other systems are also acceptable. Additional detail specific to this role's immediate responsibility below. This position will be in charge of leading the...

  • Business Specialist Processing Team Lead

    2 weeks ago

    Minneapolis, United States Box Financial Advisors Inc. Full time

    Position: Business Processing Specialist Team LeadOffice Location: 901 Marquette Ave, Suite 2800 | Minneapolis, MN 55402About Us: Box Financial is a values-driven organization that prioritizes faith, trust, excellence, and care. We aim to provide creative solutions and exceptional service, ensuring our clients' interests are paramount.Faith – To support a...

  • Business Specialist Processing Team Lead

    2 weeks ago

    Minneapolis, United States Box Financial Advisors Inc. Full time

    Position: Business Processing Specialist Team LeadOffice Location: 901 Marquette Ave, Suite 2800 | Minneapolis, MN 55402About Us: Box Financial is a values-driven organization that prioritizes faith, trust, excellence, and care. We aim to provide creative solutions and exceptional service, ensuring our clients' interests are paramount.Faith – To support a...

  • Product Support

    1 month ago

    Minneapolis, United States Upland Talent Full time

    Our Heavy Equipment Dealership Group has an opening for a Product Support - Process Support Specialist person to provide system support for parts and service operations personnel; monitor compliance with product support policies and procedures; and assist users and other system coordinators as necessary. Responsibilities: Receives and investigates all...

  • Product Support

    4 weeks ago

    Minneapolis, United States Upland Talent Full time

    Job DescriptionJob DescriptionOur Heavy Equipment Dealership Group has an opening for a Product Support - Process Support Specialist person to provide system support for parts and service operations personnel; monitor compliance with product support policies and procedures; and assist users and other system coordinators as necessary.Responsibilities:Receives...

  • Product Support

    1 month ago

    Minneapolis, United States Upland Talent Full time

    Job DescriptionJob DescriptionOur Heavy Equipment Dealership Group has an opening for a Product Support - Process Support Specialist person to provide system support for parts and service operations personnel; monitor compliance with product support policies and procedures; and assist users and other system coordinators as necessary.Responsibilities:Receives...

  • Product Support

    3 weeks ago

    Minneapolis, United States Upland Talent Full time

    Job DescriptionJob DescriptionOur Heavy Equipment Dealership Group has an opening for a Product Support - Process Support Specialist person to provide system support for parts and service operations personnel; monitor compliance with product support policies and procedures; and assist users and other system coordinators as necessary.Responsibilities:Receives...

  • Business Process Specialist | Hybrid

    2 weeks ago

    Minneapolis, United States Allianz Full time

    At Allianz Life, we are guided by our mission - we secure your future - and by our common goal of caring for tomorrow. We care for our employees by promoting an inclusive culture where everyone has the opportunity to grow and be rewarded for their success. We care for our customers by creating new products that help them protect their families and pursue...

  • Document Specialist

    3 days ago

    Minneapolis, United States Fairview Health Services Full time

    Overview: M Health Fairview's Advance Care Planning department has an immediate opening for a Documentation Specialist. This is a 1.0 FTE (80 hours per two week pay period), benefits-eligible opening. This is a Monday - Friday day shift opening. M Health Fairview offers a competitive benefits package including medical/dental, 401k/403b with employer match,...

  • Director of Actuarial Model Validation

    3 weeks ago

    Minneapolis, United States Threadneedle group Full time

    Ameriprise Financial has an exciting opportunity for Director of Actuarial Model Validation to join the team! This position will be responsible for leading and implementing model validation activities, including validation, annual review, ongoing monitoring, findings management, and model use approvals. Key Responsibilities: Manage a team of quantitative...

  • Product Support

    4 weeks ago

    Minneapolis, United States Ziegler CAT Full time

    Ziegler CAT has an opening for a Product Support - Process Support Specialist person to provide system support for parts and service operations personnel; monitor compliance with product support policies and procedures; and assist users and other system coordinators as necessary. Responsibilities: Receives and investigates all product support "help" calls...

  • Senior Process Specialist

    3 weeks ago

    Minneapolis, United States Tennant Company Full time

    With more than $1B in revenue, Tennant Company is a globally recognized leader in the cleaning equipment industry. For the past 150 years, we have been passionate about developing and manufacturing innovative and sustainable solutions for our customers. At Tennant Company, we are committed to stewardship and creating a cleaner, safer and healthier world....

  • Director of Actuarial Model Validation

    3 weeks ago

    Minneapolis, Minnesota, United States Ameriprise Financial Full time

    Ameriprise Financial has an exciting opportunity for Director of Actuarial Model Validation to join the team This position will be responsible for leading and implementing model validation activities, including validation, annual review, ongoing monitoring, findings management, and model use approvals.Key Responsibilities:Manage a team of quantitative model...