MES / Manufacturing Systems SME

Job Description

Job Description

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

MES / Manufacturing Systems SME — East Coast (Greenfield Pharma/Biotech Program)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.