MES Change Specialist

MES Change SpecialistRussell Tobin is partnering with a pharmaceutical manufacturing company to identify MES Change Specialists for an opportunity in Hillsboro, OR.Additional Details:

• Location model: Hillsboro, OR
• Position Type: 12-month contract with potential to extend
• Pay range approved: $60/hr – $70/hr, depending on experience

Responsibilities

• Troubleshoot and identify resolutions for mechanical and automation-related failures in production.
• Analyze system performance data to identify opportunities for cost reduction, process improvement, and increased operational efficiency.
• Lead user requirements gathering and conduct initial assessments for MES modifications.
• Own Computerized System Validation (CSV) activities, including requirements definition, test script development, and test execution.
• Translate operational requirements into MES recipe and workflow requirements to support CSV test protocols.
• Develop, author, and execute Configuration Verification (CV) and Functional Verification (FV) protocols for MES recipes and workflows in accordance with approved procedures and CSV principles.
• Investigate and assess exceptions and deviations identified during CV and FV protocol testing.
• Manage MES changes for assigned manufacturing processes from planning and testing through implementation, following established change management procedures.
• Monitor project schedules, identify potential risks, and escalate concerns to leadership in a timely manner.
• Assist in preparing test plans, comprehensive testing documentation, and reports for MES changes and new recipes.
• Own and manage MES-related deviations, including complex and multi-site issues associated with MES defects, and ensure corrective actions effectively address identified problems.
• Support MES-related activities for capital projects, technology transfers, Drug Substance (DS) and Drug Product (DP) changes, shutdown projects, and new product launches.
• Provide MES audit support through system demonstrations, presentations, and responses to audit questions.
• Support the resolution and closure of MES-related regulatory findings, as applicable.
• Coordinate change management activities and action items across multiple departments to ensure timely completion and compliance.Required Qualifications
• Bachelor's degree in a relevant field with 3–5 years of experience in MES, electronic batch records (EBR), or computerized systems within regulated manufacturing, or a Master's degree in a relevant field.
• Experience with the construction, testing, and validation of computerized systems.
• Experience managing electronic change control systems, such as TrackWise or Veeva, including change initiation, cross-functional coordination, and closure.
• Background in IT/OT, software technical writing, quality systems, or validation within a regulated industry.
• Understanding of electronic data system testing requirements and regulatory compliance.
• Knowledge of manufacturing automation systems, including SAP, Manufacturing Execution Systems (MES), Programmable Logic Controllers (PLC), and Human-Machine Interfaces (HMI).
• Experience with sterile pharmaceutical manufacturing processes, such as solution preparation, equipment preparation, liquid or lyophilized vial filling, prefilled syringe (PFS) operations, formulation, inspection, and packaging.
• Ability to manage multiple priorities, coordinate cross-functional activities, and maintain accurate validation and change control documentation.Preferred Qualifications
• Experience troubleshooting Rockwell automation systems, including remote and onsite support.
• Experience supporting MES or electronic batch record (EBR) deployment projects.
• Knowledge of Computerized System Validation (CSV), Computer Software Assurance (CSA), and GAMP principles.
• Experience supporting pharmaceutical manufacturing operations in a highly automated environment.APPLY NOW!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.#LI-JR1For 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 OpportunityPrideGlobal 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 EmploymentPrideGlobal 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.AccommodationsWe 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.