MES Validation Engineer - 30001_J

MES Validation Engineer

• 30001_J BEPC Inc
• 3.9 Hillsboro, OR Job Details Contract $75.00
• $83.

75 an hour 1 day ago Benefits Health insurance Dental insurance Vision insurance Life insurance Qualifications Biology Compliance risk assessment Teamwork Computer Science Engineering development testing Interpersonal skills Writing skills Bachelor's degree Test Execution (Quality assurance practices) Test Planning (Quality assurance practices) Validation design Full Job Description BEPC is actively looking for MES Validation Engineer, in Hillsboro, OR area! W2 Contract

• 6 months with possible extensions!

Benefits include medical, dental, vision, and life insurance

Pay Rate:

$75.00

• $83.75/hour
• Determined based on experience (Paid Weekly)

Work Model:

Remote role, local candidates preferred

Preferred Experience:

CSV validation, MES PharmaSuite, Writing, executing, and validating scripts, ValGenesis, Creating trace matrices.

Note :

This is a W2 only role —

C2C, C2H

will not be considered Summary of the

Role:

BEPC is seeking a highly motivated MES Validation Engineer to join our client's site in Hillsboro, OR. This role will support the multi-phase deployment of a Manufacturing Execution System (MES) and provide validation expertise for computer systems in a regulated GMP environment. The HIT team is at the forefront of bringing new medical advancements from development stages to commercial manufacturing. The team works with cutting-edge technologies such as individualized DNA/RNA therapies, cell therapies, and stem cell therapies. As a member of the MES team, you will have the opportunity to bring state-of-the-art automation technology to the site, optimizing the ability to serve patients efficiently. 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, working collaboratively with various departments and contributing to the advancement of healthcare for patients in need.

Summary of Duties and Responsibilities:

Develop, draft, and route for approval overall test scripts, validation protocols, and their associated reports for computer systems, ensuring compliance with relevant regulatory and industry standards. Work collaboratively with ITOT, system owners, quality partners, and business process owners to ensure 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 activities in a GMP environment.

Qualifications:

Education:

Bachelor's degree equivalent in: Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology, Biology, Computer Science. Experience managing testing plans and testing execution. Experience in Rockwell FactoryTalk PharmaSuite. 5 years of experience as a Validation Professional. Proven experience 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. Solid understanding of Computerized System Validation (CSV). Strong verbal and written communication skills. Experience with industry-specific tools such as ERP systems, ValGenesis, LIMS, SCADA, and other regulated life sciences platforms.

Preferred Qualifications:

Professional certifications in validation or related fields, such as: Certified Quality Engineer (CQE) Certified Software Validation Specialist (CSVS) CSV validation experience. MES PharmaSuite experience. Experience writing, executing, and validating scripts. ValGenesis experience. Experience creating trace matrices. About

BEPC BEPC

Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth. ! Qualified candidates are encouraged to apply by submitting an up-to-date resume that highlights how your experience aligns with the role. Please include specific examples that demonstrate your qualifications. We look forward to connecting with you!

USOPS Job Type:

Contract Pay:

$75.00

• $83.

75 per hour

Education:

Bachelor's (Required)

Location:

Hillsboro, OR (Preferred) Ability to

Commute:

Hillsboro, OR (Required)

Work Location:

Remote