What are the responsibilities and job description for the MES Validation Lead position at TalentBurst, an Inc 5000 company?
MES Validation Lead
Hillsboro, OR
12 Months
Description
The Hillsboro Innovative Therapies (HIT) team at *** is at the forefront of bringing new medical advancements from development stages to commercial manufacturing. We work with cutting-edge technologies such as individualized DNA/RNA therapies, cell therapies, and stem cell therapies. As a member of our Manufacturing Execution System (MES) team, you will have the opportunity to bring state of the art automation technology to our site, optimizing our ability to serve patients efficiently.
You will play a crucial role in supporting the multi-phase deployment of MES. As a Validation Lead, you will own a dynamic range of responsibilities where you will have the chance to work collaboratively with various departments and contribute to the advancement of healthcare for patients in need. You will also manage a team that is crucial to the delivery of the project.
Responsibilities
Hillsboro, OR
12 Months
Description
The Hillsboro Innovative Therapies (HIT) team at *** is at the forefront of bringing new medical advancements from development stages to commercial manufacturing. We work with cutting-edge technologies such as individualized DNA/RNA therapies, cell therapies, and stem cell therapies. As a member of our Manufacturing Execution System (MES) team, you will have the opportunity to bring state of the art automation technology to our site, optimizing our ability to serve patients efficiently.
You will play a crucial role in supporting the multi-phase deployment of MES. As a Validation Lead, you will own a dynamic range of responsibilities where you will have the chance to work collaboratively with various departments and contribute to the advancement of healthcare for patients in need. You will also manage a team that is crucial to the delivery of the project.
Responsibilities
- As the Lead Validation Engineer, you will:
- Lead the Validation team in the delivery of the MES project, ensuring that deliverables stay on track and risks and blockers are escalated in a timely manner
- Work collaboratively with ITOT, system owner, quality partners and business process owner to ensure that strategies are aligned with existing GMP systems
- Develop, draft and route for approval overall validation protocols and their associated reports for computer systems, ensuring they comply with relevant regulatory and industry standards.
- Secure transition to business post Go Live
- Be accountable for defining and documenting the validation strategy of the project
- Be responsible for ensuring that change controls and other GMP governing controls align with the validation approach
- Provide input on the project's change records, up to and including ownership of Quality records
- Provide guidance on overall test strategy and ensure alignment with existing validated computer systems
- Oversee test execution, reporting and requirements tracing
- Strong knowledge of regulatory requirements such as FDA, EMA, GxP, and industry standards related to system validation
- The ability to assess and mitigate risks associated with computer systems and ensure compliance with industry best practices
- A solid understanding of Computerized System Validation (CSV)
- Project coordination and team leadership skills
- Bachelor's degree or equivalent in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology, Biology, or a related life sciences discipline
- (Preferred) Professional certifications in validation or related fields (e.g., Certified Quality Engineer (CQE), Certified Software Validation Specialist (CSVS)).
- 5 years of experience as a Validation Professional; Proven experience in developing and executing validation protocols for computer systems
- Experience in overseeing testing plans and testing execution
- Experience with industry specific tools such as ERP systems, LIMS, SCADA, and other regulated life sciences platforms
