Validation Engineer; pharma or medical equipment manufacturing com

Job Title :
Validation Engineer (Must have experience working pharma or medical equipment manufacturing company)

Pay Rate $93/hr on W2

Duration 12 Months Contract with a possible extension

You will 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.

As a Validation Engineer, you will:

• 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

The ideal candidate brings:

• Experience in Rockwell Factory Talk Pharma Suite
• 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, Val Genesis, LIMS, SCADA, and other regulated life sciences platforms