Planet Pharma · 8 hours ago
MES Validation Engineer
Hillsboro, OR
Full-time
Onsite
Senior Level
$70/hr - $87/hr
5+ years expPlanet Pharma is at the forefront of bringing new medical advancements from development stages to commercial manufacturing. As a MES Validation Engineer, you will support the multi-phase deployment of MES and work collaboratively with various departments to enhance healthcare for patients in need.
BiotechnologyHealthcarePharmaceuticalHealth Care
Responsibilities
Develop, draft and route for approval overall test scripts, validation protocols and their associated reports for computer systems, ensuring they comply with relevant regulatory and industry standards
Work collaboratively with ITOT, system owner, quality partners and business process owner to ensure that strategies are aligned with existing GMP systems
Provide input on the validation strategy of the project
Provide guidance on overall test strategy and ensure alignment with existing validated computer systems
Execute formal validation in a GMP environment
Qualification
Required
Experience in Rockwell FactoryTalk PharmaSuite
5 years of experience as a Validation Professional; Proven experience in developing and executing validation protocols for computer systems
Strong knowledge of regulatory requirements such as FDA, EMA, GxP, and industry standards related to system validation
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)
Strong verbal and written communication skills
Bachelors degree or equivalent in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology, Biology, Computer Science 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))
Experience in managing testing plans and testing execution
Experience with industry specific tools such as ERP systems, ValGenesis, LIMS, SCADA, and other regulated life sciences platforms
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase