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Job Title: MES Change Specialist
Location: Hillsboro, OR
Duration: Contract - 7 months
Pay Range: $65/hr - $70.36/hr (W2)
Job ID: 410974
About BCforward
BCforward is a leading global IT consulting and workforce solutions firm providing services and support to Fortune 500 and government clients. Founded in 1998, BCforward has grown with our customers needs into a full-service business solutions provider. With delivery centers and offices across North America and India, we take pride in building long-term relationships and delivering excellence through innovation, collaboration, and integrity.
Job Description
We are seeking a MES Change Specialist to join our dynamic team. The ideal candidate will have strong experience in manufacturing execution systems, electronic batch records, validation, and change management and a proven ability to lead MES modifications, execute CSV activities, and improve operational efficiency through data-driven problem solving.
Responsibilities:
- Troubleshoot and resolve mechanical or automation issues impacting production.
- Identify opportunities to improve cost and efficiency using system performance data analytics.
- Lead user requirement gathering and perform initial assessments for MES modifications.
- Own CSV activities, including defining requirements and writing and executing test scripts.
- Translate operational needs into MES recipe and workflow requirements and define CSV test protocols.
- Develop, author, and execute CV and FV testing protocols for MES recipes and workflows per procedures and CSV principles.
- Investigate and assess exceptions and deviations from CV and FV testing.
- Plan, execute, and continuously improve MES change reviews for assigned processes, including testing and implementation.
- Monitor project schedules and escalate risks to leadership with time to mitigate.
- Draft comprehensive test plans and reports for MES changes and new recipes.
- Own MES-related deviations, including complex or multi-site issues, and drive effective corrective actions.
- Support MES components of site initiatives, including capital projects, tech transfers, DS/DP changes, shutdowns, and new launches.
- Serve as audit support for MES, provide demonstrations and presentations, and support closure of MES-related regulatory findings.
Required Skills & Qualifications:
- Bachelor's degree in a relevant field with 3-5 years in MES, EBR, or computerized systems for regulated manufacturing, or a Master's degree in a relevant field.
- Experience in construction, testing, and validation of computerized systems.
- Extensive experience with electronic change management systems such as TrackWise or Veeva.
- Background in IT, OT, Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP) in a regulated setting.
- Strong understanding of test requirements for electronic data systems to ensure regulatory compliance.
- Knowledge of SAP, MES, PLCs, and HMIs.
- Experience in sterile pharmaceutical manufacturing processes such as solution preparation, equipment preparation, vial filling, PFS, formulation, inspection, and packaging.
- Proven ownership of changes from initiation to closure within systems like Veeva.
Preferred Skills:
- Experience troubleshooting Rockwell systems, including remote or on-site support.
- Prior participation in EBR or MES deployment projects.
Why BCforward?
At BCforward, we believe in advancing lives and careers. When you join our team, you gain access to:
- Competitive compensation and benefits.
- Opportunities for growth with global clients.
- A supportive, inclusive culture that values innovation and people.
- Exposure to cutting-edge technologies and projects.
About Our Commitment
BCforward is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, or veteran status.
Interested? Apply Now!
If this sounds like the right opportunity for you, please apply with your most recent resume.
