Sharp DecisionsRemote
Validation Engineer (Must have experience working pharma or medical equipment manufacturing company)”
United States
Full-time
1 week ago
$93 USD
H1B Sponsor Likely
Key skills
Rockwell FactoryTalk PharmaSuiteValidation protocols developmentRegulatory knowledge FDARegulatory knowledge EMAComputerized System Validation (CSV)Risk assessmentmitigationProfessional certificationsTesting plans managementBachelor's degree in related fieldcommunication skillsERPCommunication
About this role
Sharp Decisions is seeking a Validation Engineer to support the multi-phase deployment of MES. In this role, you will develop validation protocols and ensure compliance with regulatory standards while collaborating with various departments to enhance healthcare solutions.
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
Requirements:
- Must have experience working pharma or medical equipment manufacturing company
- 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
- 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