MES Change Specialist

Job Title: MES Change Specialist

Job Description

The MES Change Specialist plays a key role within the Process and Compliance Team in a highly automated pharmaceutical production and packaging facility. In this position, you design, build, test, validate, and maintain electronic documentation and Manufacturing Execution System (MES) workflows that support compliant, efficient manufacturing operations. You work cross-functionally with manufacturing, process compliance, IT/OT, master data, and other departments to ensure that MES recipes, electronic batch records, and related systems are robust, accurate, and aligned with regulatory and operational requirements.

Responsibilities

• Troubleshoot and identify resolutions for mechanical or automation-related failures in production, collaborating with operations and technical teams to restore reliable performance.
• Identify and drive opportunities for process improvement by leveraging data analytics on system performance to reduce costs and increase efficiency.
• Lead user requirement gathering activities for operational needs and perform initial requirement assessments for MES modifications and enhancements.
• Own computer system validation (CSV) activities, including defining requirements and authoring and executing test scripts for MES changes and electronic batch records.
• Translate operational requirements into detailed MES recipe and workflow requirements that form the basis for CSV test protocols.
• Develop, author, and execute protocols for configuration verification (CV) and functional verification (FV) testing of 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, ensuring appropriate documentation and resolution.
• Plan, execute, and continuously improve the review of MES changes for assigned manufacturing processes, following formal change management processes including testing and implementation.
• Monitor project schedules for MES-related activities and escalate concerns to leadership with sufficient lead time to mitigate risks and maintain timelines.
• Assist with drafting comprehensive test plans and reports for MES changes, including new recipes and workflow implementations.
• Own MES-related deviations, including high-complexity or multi-site deviations related to MES defects, and ensure that corrective actions effectively resolve underlying issues.
• Support MES components of broader site initiatives, including capital projects, technology transfers, Drug Substance and Drug Product (DS/DP) changes, shutdown projects, and new product launches.
• Serve as audit support for MES, providing demonstrations, presentations, and clear responses to questions from auditors and stakeholders.
• Support closure of MES-related regulatory findings by providing technical input, documentation, and evidence of effective remediation.
• Utilize electronic change management systems to initiate, manage, and close changes, coordinating action items across multiple departments.

Essential Skills

• Bachelors degree in a relevant field plus 35 years of MES, electronic batch record, or computerized systems experience in regulated manufacturing, or a Masters degree in a relevant field.
• Hands-on experience with construction, testing, and validation of computerized systems in a regulated environment.
• Extensive experience working in electronic change management systems such as TrackWise, Veeva, or similar platforms to own changes and coordinate cross-functional action items.
• Strong understanding of computer system validation and assurance principles (CSV/CSA) and application of GAMP guidelines.
• Deep knowledge of test requirements for electronic data systems to ensure regulatory compliance.
• Working knowledge of 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 and lyophilized vial filling, pre-filled syringe formulation, inspection, and packaging.
• Demonstrated ownership of changes in a change management system (for example, Veeva) from initiation through closure.
• Experience troubleshooting Rockwell automation systems, with remote or on-site support strongly preferred.
• Experience with MES and electronic batch record (EBR) deployment projects.
• Ability to interpret operational requirements and convert them into structured MES recipes, workflows, and test documentation.
• Strong analytical skills and proficiency in using data to diagnose issues and identify improvement opportunities.

Additional Skills & Qualifications

• Prior experience in IT or OT environments supporting manufacturing systems and infrastructure.
• Experience in software technical writing, with the ability to create clear, compliant system documentation and test protocols.
• Experience in quality systems management and validation activities within a regulated industry.
• Familiarity with SAP in a manufacturing context, particularly integration with MES and automation systems.
• Comfort working with highly automated production and packaging technologies in pharmaceutical or similarly regulated sectors.
• Ability to collaborate effectively across manufacturing, engineering, quality, IT/OT, and master data teams.
• Strong communication skills for explaining complex technical concepts to diverse stakeholders and supporting audits.
• Detail-oriented mindset with a focus on accuracy, compliance, and continuous improvement.

Work Environment

This role is based onsite in Hillsboro, OR within a state-of-the-art, highly automated pharmaceutical production and packaging facility. You work closely with manufacturing operations, process compliance, IT/OT, quality, and engineering teams in a regulated environment that emphasizes data integrity, electronic documentation, and robust automation. The position involves hands-on interaction with MES, SAP, PLCs, HMIs, Rockwell systems, and electronic change management platforms such as TrackWise and Veeva. You can expect a dynamic setting with active participation in capital projects, technology transfers, shutdown activities, and new product launches, along with regular engagement in audits and regulatory inspections.

This is a Contract position based out of Hillsboro, OR.

The pay range for this position is $64.00 - $67.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a Contract position based out of Hillsboro, OR.

This position is anticipated to close on Oct 19, 2026.

This is a fully onsite position in Hillsboro,OR.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.