MES Validation Engineer

Nesco Resource, LLC

Hillsboro, OR

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JOB DETAILS

SALARY

$70–$81.43 Per Hour

SKILLS

Automation, Best Practices, Biochemistry, Biology, Biomedical Engineering, Business Processes, Certified Quality Engineer (CQE), Chemistry, Communication Skills, Computer Science, Computer Systems, DNA, ERP (Enterprise Resource Planning), FDA Requirements, GMP (Good Manufacturing Practices), GxP, Healthcare, Industry Standards, Laboratory Information Management System (LIMS), Leading Edge Technology, Maintain Compliance, Manufacturing, Manufacturing Execution Systems (MES), People Management, Presentation/Verbal Skills, Regulations, Risk Analysis, Risk Management, Software Validation, Stem Cells, Supervisory Control and Data Acquisition (SCADA), System Validation, Test Plan/Schedule, Test Scripts, Test Strategy, Validation Plan, Writing Skills

LOCATION

Hillsboro, OR

POSTED

4 days ago

The Hillsboro Innovative Therapies (HIT) team at Genentech is at the forefront of bringing new medical advancements from development stages to commercial manufacturing. We work with cutting-edge technologies such as individualized DNA/RNA therapies, cell therapies, and stem cell therapies. As a member of our Manufacturing Execution System (MES) team, you will have the opportunity to bring state of the art automation technology to our site, optimizing our 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 where you will have the chance to work collaboratively with various departments and contribute to the advancement of healthcare for patients in need.

Responsibilities
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

Who you are
The ideal candidate brings:
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
Bachelor's degree or equivalent in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology, Biology, Computer Science or a related life sciences discipline
(Preferred) 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

Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

About the Company

Nesco Resource, LLC

Companies need talent. You want job opportunities.

That’s where we come in. We create meaningful connections between companies and candidates, and we’ve been doing it for over 65 years.
Our national workforce solutions include contract, contract-to-hire, direct placement services, and managed services for a variety of industries.

We employ specialized recruiters focused in Engineering, Information Technology, Accounting & Finance, Administrative & Customer Service, and Manufacturing & Distribution.

When you need to find a job, we're your partner.

COMPANY SIZE

10,000 employees or more

INDUSTRY

Staffing/Employment Agencies

EMPLOYEE BENEFITS

Paid Sick Days, Parking, Performance Bonus, Employee Referral Program

FOUNDED

1956

WEBSITE

https://nescoresource.com/

MES Validation Engineer

Nesco Resource, LLC

Hillsboro, OR

About the Company

Nesco Resource, LLC

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