MES / Manufacturing Systems SME
Role Overview
Provide subject-matter expertise for MES, electronic batch records, manufacturing workflows, and integration with automation and enterprise systems. This is an owner-side, program-focused role requiring coordination across multiple stakeholders, suppliers, and delivery teams rather than a narrowly scoped execution-only assignment.
Key Skills for This Role
Full Job Posting
Business Justification
Provide subject-matter expertise for MES, electronic batch records, manufacturing workflows, and integration with automation and enterprise systems.
Position Overview
Provide subject-matter expertise for MES, electronic batch records, manufacturing workflows, and integration with automation and enterprise systems. This is an owner-side, program-focused role requiring coordination across multiple stakeholders, suppliers, and delivery teams rather than a narrowly scoped execution-only assignment.
Key Responsibilities
- Translate manufacturing and quality requirements into MES, EBR, recipe, workflow, and master-data solutions.
- Support MES architecture, design reviews, requirements, configuration oversight, testing, validation, deployment, and stabilization.
- Coordinate interfaces with DCS/PLC/SCADA, ERP, LIMS, historians, CMMS, and data platforms.
- Support business process mapping, electronic record design, exception handling, data integrity, and operational readiness.
- Partner with manufacturing, quality, automation, IT/OT, CSV, and system integrators.
Required Qualifications
- Bachelor’s degree in engineering, computer science, information systems, or related field, or equivalent experience.
- 8+ years of MES or manufacturing systems experience in pharmaceutical or biotech manufacturing.
- Hands-on experience with EBR/MBR design, recipe/workflow configuration, MES validation, and regulated manufacturing processes.
- Experience with one or more enterprise MES platforms and integrations using ISA-88/ISA-95 concepts.
Preferred Qualifications
- Experience on a greenfield or major capital pharmaceutical manufacturing program.
- Demonstrated success operating in an owner-side, EPCM, governance, or provider-oversight model.
- Strong written communication, executive reporting, facilitation, and cross-functional issue-resolution skills.
- Ability to maintain significant site presence as the program advances.
Why Join Valspec?
At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including:
Premium medical coverage
401(k) with company match
Tuition reimbursement
Unique performance incentives
And more — all designed to support your growth, well-being, and future.
Join a team where your contributions matter, your development is prioritized, and your success is shared.
When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored.
Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.
Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.
Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
About Valspec
An ESOP consulting firm providing digital and conventional validation and lifecycle services to life sciences manufacturers.
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