Our goal is to redefine IT staffing by embracing diversity and inclusion, connecting clients with exceptional and skilled professionals who bring innovative solutions while fostering an environment where every individual feels valued and empowered to thrive.
MES Validation Engineer
Type: Contract, W2 only
Duration: 6+ months
Location: remote
Pay: $66/hr-$85.5/hr, DOE
Please note that at this time we are unable to sponsor employment authorization (both new and transfer)
A leading Global Biotech Company is seeking a MES Validation Engineer to play a crucial role in supporting the multi-phase deployment of MES. As a Validation Engineer, 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.
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 IT/OT, 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.
Qualifications:
- 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).
- 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
- 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) (Preferred).
We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs.