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TalentBurst, an Inc 5000 company provided pay range

This range is provided by TalentBurst, an Inc 5000 company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$50.00/hr - $70.00/hr

Location: Hillsboro, OR (Remote, Open to someone who can travel to the site about once a month on average at their expenses).

Duration: 12+ months Contract (with the possibility of extension)

Job Description:

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.

Education and Experience:

• 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
• 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

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Engineering, Science, and Research

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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