MES Change Specialist

Pride Global; Hillsboro (OR); On-site; USD 90,000 - 96,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) retirement savings

Life & disability insurance

Employee discounts

Equal opportunity employer

Job summary

Pride Global is seeking an experienced MES/CSV professional for an onsite Hillsboro, OR contract role. You will troubleshoot automation in production, drive MES changes, and own CSV test protocols across multiple departments.

Responsibilities include validating CV/FV for MES recipes, coordinating change management, and supporting site initiatives. Prior experience with regulatory compliance and IT/OT is highly valued. This is an 8+ month assignment with competitive hourly pay.

Qualifications

• Bachelor's degree plus 3–5 years MES/electronic batch record experience or a Master's degree
• Experience with construction, testing, and validation of computerized systems
• Extensive experience with electronic change management systems (Trackwise, Veeva, etc.) to own changes across departments
• Experience in IT/OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP)
• Strong understanding of test requirements for electronic data systems for regulatory compliance

Responsibilities

• Troubleshoot and resolve mechanical or automation failures in production
• Lead requirements gathering for MES modifications and assess initial requirements
• Own CSV functions including writing and executing test scripts
• Translate operational requirements into recipe/workflow requirements for CSV test protocols
• Develop, author, and execute CV and FV testing of MES recipes/workflows
• Investigate deviations from CV/FV protocols and assess exceptions
• Plan, execute, and improve review of MES changes across manufacturing processes
• Monitor project schedule and escalate concerns to leadership
• Draft test plans for MES changes and prepare comprehensive test reports
• Own MES-related deviations and ensure effective corrective actions
• Support MES components of site initiatives and capitalized projects
• Provide audit support for MES with demonstrations and regulatory responses

Skills

MES knowledge

CSV testing

Data analysis

Trackwise

Veeva

Rockwell troubleshooting

Regulatory manufacturing

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field

Tools

SAP

MES

PLC

HMI

Job description

$65.00-$70.50 per hour Hillsboro, OR Onsite

Job Description

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 elevate 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.

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

Benefits

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
• 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.