MES Change Specialist

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 productionYou 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 modificationsYou will own CSV functions including defining requirements, writing and execution of test scriptsTranslate operational requirements into recipe and workflow requirements that will define CSV test protocolsDevelopment, 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 principlesInvestigate and assess exceptions and deviations from CV and FV protocol testingYou 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 implementationYou will monitor project schedule and escalate concerns to leadership with appropriate time to mitigateYou will assist with drafting test plans for MES changes, including comprehensive test plans and/or reports for new recipesYou will own MES-related deviations, including high-complexity or multi-site deviations relating to MES defects. Ensure corrective actions resolve issues effectivelyYou will support MES-components of other site initiatives, including capitalized projects, tech transfers, Drug Substance/Drug Product (DS/DP) changes, shutdown projects, and new launchesYou 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 fieldYou have prior experience with construction, testing, and validation of computerized systemsYou have extensive prior experience working in electronic change management systems (trackwise, Veeva, etc.) to own changes and coordinate action items spanning multiple departmentsPrior 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 complianceYou 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 closureYou have experience with troubleshooting Rockwell systems, including remote or on-site support, is strongly preferredIt is preferred you have prior experience on an EBR or MES deployment projects.Additional Details:

• Location: Hillsboro, OR.
• Duration: 08+Months (Possible extension)
• Pay rate: $65–$70.50/yr. depending on experienceAPPLY 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.Benefits disclosure: 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 its 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.