Automation Project Manager in Carolina 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 to lead the development, planning, and execution of Automation and IT Capital Projects. In this role, you will serve as both the project execution leader and technical authority, coordinating Engineering, Quality, Validation, IT, and external vendors while delivering projects on time, within budget, and in full compliance with cGMP and pharmaceutical regulatory standards.
You will provide subject matter expertise across PLC, SCADA, DeltaV, and MES (Syncade) platforms, while managing the full Computer System Validation (CSV) lifecycle and ensuring that all project activities meet FDA, 21 CFR Part 11, and applicable Quality Practice requirements.
RESPONSIBILITIES
- Capital Project Leadership: Lead the end-to-end development, planning, and execution of Automation and IT Capital Projects from initiation through closeout, ensuring on-time and on-budget delivery against approved scope.
- Technical Authority: Act as the technical lead for all automation systems, providing SME-level expertise for PLCs, SCADA, DeltaV, and MES (Syncade) in support of design decisions, troubleshooting, and system optimization throughout the project lifecycle.
- Cross-Functional Coordination: Coordinate Engineering, Quality, Validation, IT, and external vendors; facilitate alignment meetings; drive issue resolution; and maintain clear communication across all disciplines and stakeholder groups.
- CSV Lifecycle Management: Ensure the full Computer System Validation lifecycle is executed in compliance with cGMP, FDA regulations, and 21 CFR Part 11, including documentation development, protocol execution, and formal review and approval.
- Compliance & Regulatory Readiness: Ensure all project activities adhere to cGMP, FDA 21 CFR Part 11, and applicable Quality Practices; support internal audits and regulatory inspections as needed.
- Project Documentation & Reporting: Develop and maintain project plans, integrated schedules, change control documentation, risk logs, and status reports for leadership and regulatory readiness throughout the project lifecycle.
- Budget & Schedule Management: Track project expenditures and resource allocation against approved budgets and capital appropriation requests (CARs); identify variances early and implement corrective actions to maintain financial and schedule targets.
- Vendor & Contractor Management: Manage external vendors and contractors, ensuring technical deliverables, documentation, and performance commitments are met in alignment with project requirements and site standards.
REQUIREMENTS & QUALIFICATIONS
Required
- Bachelor's degree in Engineering (Electrical, Computer, Mechanical, or related discipline) or Information Technology.
- Minimum 6–8 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 the Computer System Validation (CSV) lifecycle.
- Proven track record coordinating cross-functional teams including Engineering, Quality, IT, Validation, and external vendors.
- Experience managing capital appropriation requests (CARs) and project budgets.
- 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.
- Background in Lean Manufacturing or Six Sigma methodologies.
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, CAPA management, and audit readiness
- Cross-functional coordination: Engineering, Quality, IT, Validation, Vendors
- Capital Appropriation Request (CAR) management
- Microsoft Office 365 — Project, Excel, Word, Teams
Soft Skills
- Dual-mode leader — equally effective as technical authority and project execution driver
- Strategic planner with hands-on accountability for project outcomes
- Proactive risk identifier with the decisiveness to act before issues escalate
- Skilled at aligning diverse stakeholder groups around shared project objectives
- Rigorous in compliance documentation and regulatory readiness
- Composed and effective in high-complexity, fast-paced environments