MES Change Specialist

Actalent; Hillsboro (OR); Vor Ort; USD 11.000 - 16.000; Vollzeit

Benefits dieser Stelle

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

Health Spending Account (HSA)

Zusammenfassung

Actalent seeks a MES Change Specialist to design, validate, and maintain MES recipes and electronic documentation in a Hillsboro, OR facility. You will collaborate across manufacturing, IT/OT, quality, and master data teams to ensure compliant electronic batch records and workflows.

The role emphasizes CV/FV testing, CSV activities, and deviations resolution within a formal change management process, with a focus on cross-functional collaboration and regulatory compliance.

Qualifikationen

• Bachelor's degree in a relevant field with MES/electronic batch record experience in regulated manufacturing.
• Experience constructing, testing, and validating computerized systems in a regulated environment.
• Experience using electronic change management systems like TrackWise or Veeva to coordinate cross-functional activities.

Aufgaben

• Troubleshoot automation-related production failures to maintain reliability.
• Analyze system performance data for process improvements and cost reductions.
• Lead user requirement gathering and assess MES modifications.

Kenntnisse

MES

Electronic batch records

CSV/CSA/GAMP

TrackWise

Veeva

Rockwell automation

SAP

HMI/PLC

Ausbildung

Bachelor's degree in a relevant field

Master's degree in a relevant field

Tools

TrackWise

Veeva

SAP

HMI/PLC

Jobbeschreibung

Job Title: MES Change SpecialistJob Description

The MES Change Specialist supports a highly automated pharmaceutical production and packaging facility by designing, building, testing, validating, and maintaining manufacturing execution system (MES) recipes and electronic documentation. This onsite role in Hillsboro, OR operates within the Process and Compliance team, working cross-functionally with manufacturing, process control, IT/OT, master data, and other departments to ensure efficient construction and reliable functionality of electronic batch records and workflows across the site.

Responsibilities

• Troubleshoot and resolve mechanical and automation-related failures in production to maintain reliable operations.


• Analyze system performance data to identify opportunities for process improvement, cost reduction, and increased efficiency.


• Lead the gathering of user requirements for operational needs and perform initial assessments for MES modifications.


• Own computer system validation (CSV) activities, including defining requirements and authoring and executing test scripts.


• Translate operational requirements into MES recipe and workflow specifications that define 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 arising from CV and FV protocol testing, and support resolution activities.


• Plan, execute, review, and continuously improve MES changes for assigned manufacturing processes as part of the formal change management process, including testing and implementation.


• Monitor project schedules for MES-related activities and elevate concerns to leadership in time to enable effective mitigation.


• Assist in drafting comprehensive test plans and reports for MES changes, including new and updated recipes.


• Own MES-related deviations, including high-complexity or multi-site deviations linked to MES defects, and ensure corrective actions effectively resolve underlying issues.


• Support MES components of broader site initiatives, including capital projects, technology transfers, Drug Substance/Drug Product (DS/DP) changes, shutdown projects, and new product launches.


• Serve as audit support for MES by providing demonstrations, presentations, and responses to auditor questions, and contribute to the closure of MES-related regulatory findings.


• Maintain accurate document control and quality assurance practices related to MES configurations, changes, and test documentation.


• Coordinate action items and approvals across multiple departments within electronic change management systems to drive changes from initiation through closure.

Essential Skills

• Bachelors degree in a relevant field with 35 years of MES, electronic batch record, or computerized systems experience in regulated manufacturing, or a Masters degree in a relevant field.


• Demonstrated experience in the construction, testing, and validation of computerized systems in a regulated environment.


• Extensive experience using electronic change management systems such as TrackWise, Veeva, or similar platforms to own changes and coordinate cross-functional activities.


• Prior experience in IT, OT, software technical writing, quality systems, and validation (CSV/CSA, GAMP) within a regulated industry.


• Strong understanding of test requirements for electronic data systems to meet regulatory compliance expectations.


• Knowledge of automation systems including SAP, Manufacturing Execution Systems (MES), Programmable Logic Controllers (PLC), and Human Machine Interfaces (HMI).


• Hands-on experience with sterile pharmaceutical manufacturing processes such as solution preparation, equipment preparation, liquid and lyophilized vial filling, pre-filled syringe (PFS) formulation, inspection, and packaging.


• Proven ownership of changes in electronic change management systems (for example, Veeva) from initiation through closure.


• Experience troubleshooting Rockwell automation systems, with remote or onsite support strongly preferred.


• Ability to author and execute CSV protocols, including CV and FV testing, and to manage related deviations and corrective actions.


• Strong document control and quality assurance skills related to MES and computerized systems.


• Ability to work effectively in cross-functional teams and communicate clearly with manufacturing, IT/OT, quality, and other stakeholders.

Additional Skills & Qualifications

• Preferred prior experience on electronic batch record (EBR) or MES deployment projects, including implementation and go-live support.


• Familiarity with capital project environments, technology transfer activities, DS/DP changes, shutdown planning, and new product launch coordination.


• Experience supporting audits and regulatory inspections focused on MES and computerized systems.


• Understanding of data analytics tools and methods to evaluate system performance and drive continuous improvement.


• Knowledge of CSV/CSA and GAMP best practices for pharmaceutical and other regulated industries.


• Strong analytical, problem-solving, and root-cause investigation skills for automation and MES-related issues.


• Ability to manage multiple concurrent MES changes and projects while maintaining compliance and documentation quality.

Work Environment

This position is based onsite in a state-of-the-art, highly automated pharmaceutical production and packaging facility in Hillsboro, OR. The work environment combines manufacturing floor exposure with office-based tasks, requiring close collaboration with operations, quality, engineering, and IT/OT teams. You will regularly interact with MES platforms, SAP, PLCs, HMIs, Rockwell systems, and electronic change management tools such as TrackWise and Veeva. Work involves hands-on engagement with sterile manufacturing processes, equipment preparation, vial filling, pre-filled syringe formulation, inspection, and packaging operations, as well as participation in audits and project activities. The role operates within a structured, compliance-focused setting that emphasizes safety, data integrity, and adherence to established procedures and validation standards.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $10.00 - $10.00/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)

Job Type & Location

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

Application Deadline

This position is anticipated to close on Oct 27, 2026.

Workplace Type

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 [e-mail] 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.