MES Validation Engineer
Company: SQA Solution
Location: Hillsboro
Posted on: February 15, 2026
|
|
|
Job Description:
Job Description Job Description Type : Contract, W2 only
Duration : 4 months Location : Hillsboro, OR; open to remote Pay :
$66/hr-$93/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.
Keywords: SQA Solution, Corvallis , MES Validation Engineer, IT / Software / Systems , Hillsboro, Oregon
