Automation PM - SME Project Engineer Support in Manati at JC Automation Corp
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Job Description
About Company:
JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.
JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.
ABOUT THE ROLE
We are seeking a highly experienced Automation Project Manager and Subject Matter Expert (SME) to lead the development, planning, and execution of Automation and IT Capital Projects within a cGMP pharmaceutical manufacturing environment. In this dual role, you will serve as both the technical authority and the project execution leader.
You will coordinate Engineering, Quality, Validation, IT, and external vendors while providing deep technical expertise in PLCs, SCADA, DeltaV, and MES systems. You will also ensure full compliance with cGMP, FDA regulations, and the Computer System Validation (CSV) lifecycle throughout all project phases.
RESPONSIBILITIES
- Capital Project Leadership: Lead the development, planning, and execution of Automation/IT Capital Projects from initiation through closeout, ensuring on-time and on-budget delivery.
- Technical Lead: Act as the technical lead for all automation systems, coordinating Engineering, Quality, Validation, IT, and external vendors throughout the project lifecycle.
- SME Support: Provide subject matter expertise for systems including PLCs, SCADA, DeltaV, and MES (Syncade), supporting design decisions, troubleshooting, and system optimization.
- Compliance Management: Ensure all project activities comply with cGMP, FDA regulations, and 21 CFR Part 11, and support the Computer System Validation (CSV) lifecycle.
- Cross-Functional Coordination: Facilitate alignment meetings, drive issue resolution, and maintain clear communication across all disciplines and stakeholder groups.
- Documentation & Reporting: Develop and maintain project plans, schedules, change control documentation, and status reports for leadership and regulatory readiness.
REQUIREMENTS & QUALIFICATIONS
Required
- Bachelor's degree in Engineering (Electrical, Computer, Mechanical, or related discipline) or Information Technology.
- Minimum 5–7 years of experience in automation project management within a pharmaceutical or biotech GMP environment.
- Demonstrated SME-level expertise in PLCs, SCADA, DeltaV, and/or MES systems (Syncade preferred).
- Strong knowledge of cGMP, FDA 21 CFR Part 11, and CSV lifecycle requirements.
- Proven experience coordinating cross-functional teams including Engineering, Quality, IT, and external vendors.
- Bilingual in English and Spanish (oral and written).
Preferred
- PMP certification or equivalent project management credential.
- Experience managing Syncade MES upgrade or implementation projects.
- Familiarity with GAMP 5 methodology for CSV.
- Experience managing capital appropriation requests (CARs) and project budgets.
SKILLS
Technical Skills
- PLCs, SCADA, DeltaV, MES (Syncade) — SME level
- Computer System Validation (CSV) lifecycle management
- cGMP, 21 CFR Part 11, and GAMP 5 compliance
- Capital project planning, scheduling, and cost control
- Change control and CAPA management
- Cross-functional team coordination (Engineering, Quality, IT, Validation, Vendors)
- Microsoft Office 365 — Project, Excel, Word, Teams
Soft Skills
- Technical authority combined with executive-level communication
- Strategic project leadership with hands-on accountability
- Proactive risk identification and mitigation
- Ability to align diverse stakeholder groups around project objectives
- Disciplined in compliance documentation and regulatory readiness
- Composure and decisiveness in high-complexity environments