MES Change Specialist

Russell Tobin; Hillsboro (OR); On-site; USD 65,000 - 71,000; Full time

Job summary

Russell Tobin is partnering with a top pharmaceuticals and diagnostics company in Hillsboro, OR to identify an MES Change Specialist. The role focuses on troubleshooting MES, CSV, CV, FV testing, and change management across manufacturing processes.

Requirements include a bachelor's (or master’s) in a relevant field with 3–5 years’ MES or electronic batch record experience, trackwise/Veeva exposure, and strong regulatory knowledge. On-site position with extended duration and competitive pay.

Qualifications

• Bachelor's degree in a relevant field with 3–5 years MES, electronic batch record, or computerized systems experience; or a Master's degree in a relevant field.
• Experience with construction, testing, and validation of computerized systems.
• Experience with electronic change management systems (Trackwise, Veeva) to own changes and coordinate actions across departments.
• IT/OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP) in regulated environments.
• Understanding test requirements for electronic data systems for regulatory compliance.
• Knowledge of SAP, MES, PLCs, and HMI in automation environments.

Responsibilities

• Troubleshoot and identify resolutions for mechanical or automation failures in production.
• Lead data analytics to improve performance, reduce costs, and increase efficiency.
• Own changes in MES, from initiation to closure, across multiple processes.
• Develop, author, and execute protocols for CV and FV testing of MES recipes and workflows.
• Draft test plans and reports for MES changes, including new recipes and regression testing.

Skills

MES

Electronic Batch Record

Computerized systems

IT/OT knowledge

Regulatory compliance

Education

Bachelor's degree in relevant field

Master's degree in relevant field

Tools

Trackwise

Veeva

Job description

Job Description

Job Description

Russell Tobin is partnering with a top pharmaceuticals and diagnostics company to identify a MES Change Specialist in Hillsboro, OR .

Responsibilities

• You will troubleshoot and identify resolutions for mechanical or automation related failures in production
• You will identify opportunities to improve leveraging data analytics of system performance to deliver reduced costs and increased efficiency.
• You will lead user requirement gathering for operational needs and perform initial requirement assessments for MES modifications
• You will own CSV functions including defining requirements, writing and execution of test scripts
• Translate operational requirements into recipe and workflow requirements that will define CSV test protocols
• Development, authoring, and executing of protocols for configuration verification (CV) and functional verification (FV) testing of MES recipes and workflows according to approved procedures and CSV principles
• Investigate and assess exceptions and deviations from CV and FV protocol testing
• You will own plan, execute, and improve review of MES changes for a set of assigned manufacturing processes driven by the change management process, including testing and implementation
• You will monitor project schedule and escalate concerns to leadership with appropriate time to mitigate
• You will assist with drafting test plans for MES changes, including comprehensive test plans and/or reports for new recipes
• You will own MES-related deviations, including high-complexity or multi-site deviations relating to MES defects. Ensure corrective actions resolve issues effectively
• You will support MES-components of other site initiatives, including capitalized projects, tech transfers, Drug Substance/Drug Product (DS/DP) changes, shutdown projects, and new launches
• You will serve as an audit support for MES, providing demonstrations, presentations, and answering questions as required. If topical, support closure of any MES-related regulatory findings.

Russell Tobin is a professional recruitment and staffing advisory firm that connects job seekers and employers across various industries. We are a staffing arm of Pride Global. Affiliates include Russell Tobin, Pride health, Pride Now and Pride One.

Requirements

• You hold a bachelor's degree in a relevant field plus 3-5 years of MES, electronic batch record, or computerized systems experience for regulated manufacturing OR Master's degree in a relevant field
• You have prior experience with construction, testing, and validation of computerized systems
• You have extensive prior experience working in electronic change management systems (Trackwise, Veeva, etc.) to own changes and coordinate action items spanning multiple departments
• Prior experience in IT, OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP), preferably in a regulated industry.
• You have a strong understanding of test requirements for electronic data systems for regulatory compliance
• You have knowledge of the automation systems that include SAP, Manufacturing Execution Systems (MES), Programmable Logic Controllers (PLC) and Human Machine Interfaces (HMI)
• You have prior experience with sterile pharmaceutical manufacturing (solution prep, equipment prep, liquid/lyo vial filling, PFS, formulation, inspection, packaging, etc)
• Ownership of changes in a change management system (ex. Veeva) from initiation to closure
• You have experience with troubleshooting Rockwell systems, including remote or on-site support, is strongly preferred
• It is preferred you have prior experience on an EBR or MES deployment projects.

Additional Details

• Location: Hillsboro, OR.
• Duration: 8+Months (Possible extension)
• Pay rate: $65–$70.50/yr. depending on experience

For workers in the United States, PrideGlobal and it's affiliates offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, pet insurance and employee discounts with preferred vendors.

Equal Employment Opportunity

PrideGlobal and it's affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.

Fair Chance Employment

PrideGlobal and it's affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.

Accommodations

We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.

Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.

Only applicable for Kentucky positions: For this type of employment, state law requires a criminal record check as a condition of employment. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793.

Company Description

Russell Tobin is a leading professional recruitment and staffing advisory organization. We are comprised of specialized practices focusing on a variety of skill sets and industries. With deep industry expertise, our subject matter experts provide tailored and swift sourcing solutions to fulfill client hiring needs. In other words, we connect top talent with companies.

We are the staffing arm of the Pride Global network, an integrated human capital solutions firm, with additional offerings in vendor management, payroll programs, and business process optimization.