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
The Automation SME – Project Engineer is accountable for technical leadership and project coordination of assigned Automation/IT capital projects. Execution activities may be performed directly by the resource or through oversight and coordination of contractors and system integrators. As a candidate, your company must meet BMS policies, guidelines, and other requirements.
2.1. Capital Project Execution
- Lead the development, planning, and execution of Automation/IT/Network Capital Projects.
- Act as the technical project lead for Automation/IT scope, coordinating engineering, quality, validation, IT, and vendors through all project phases.
- Define project scope, schedules, cost estimates, risks, and deliverables.
- Provide routine project status reporting, milestone tracking, and risk mitigation plans.
- Resolve complex technical and design issues arising during project execution, construction, and start‑up, ensuring decisions support regulatory compliance, safety, product quality, cost, and schedule objectives.
- Provide clear and timely communication on Project Engineering activities, risks, and milestones to internal stakeholders and management. Support Capital Appropriation Requests (CARs), budgeting, and financial tracking.
- Coordinate project execution activities with EHS to ensure compliance with safety, environmental, and waste‑handling requirements throughout all project phases.
- Review vendor quotations, develop technical specifications, and support procurement activities, including purchase requisitions and technical evaluation of equipment and services for Automation/IT capital projects.
2.2. Automation and Systems Engineering
- Lead and/or support the design, specification, procurement, installation, commissioning, and start-up of automation and computerized systems.
- Provide SME support for systems including, but not limited to:
- PLCs, HMI, SCADA, DCS/BAS o DeltaV, Rockwell Automation, FactoryTalk, Siemens, Wonderware o MES systems (e.g., Syncade), data historians (OSI PI), databases (MS SQL), and virtualization platforms
- Review and approve automation architectures, network designs, and system configurations.
- Identify and promote best available automation technologies to meet site and corporate needs. 2.3. Compliance, Quality, and Validation
- Ensure all project activities comply with: o cGMP, FDA, EMA, OSHA, EPA/EQB o 21 CFR Part 11, Engineering, IT, and Security standards
- Support execution of the Computer System Validation (CSV) lifecycle, including requirements, specifications, testing, and qualification.
- Support Performance Qualification (PQ) of equipment and systems installed under capital projects.
- Participate in quality events, including deviations, investigations, CAPAs, internal audits, and regulatory inspections related to automation systems.
- Ensure Automation and computerized systems are delivered in a validated state, in compliance with CSV requirements.
- Support preparation, review, and execution of validation documentation.
2.4. Contractor and Vendor Management
- Manage and coordinate external contractors, system integrators, and vendors.
- Ensure contractor compliance with safety, environmental, security, and quality requirements.
- Review technical proposals, quotations, and specifications.
- Coordinate FAT, SAT, commissioning, and start-up activities with vendors and internal stakeholders.
- Ensure quality of construction, installation, and system implementation activities for Automation and related infrastructure in accordance with approved designs, specifications, and GMP requirements.
2.5. Documentation and Change Control
- Develop, review, and maintain technical and project documentation, including:
- URS, FRS, DS, and configuration documents.
- SOPs (Operations, Maintenance, Security, Backup/Restore, Disaster Recovery).
- Execute and support change control activities related to automation and computerized systems.
- Ensure proper documentation control, traceability, and data integrity.
2.6. Cross‑Functional Collaboration
- Serve as the Automation Project SME for Manufacturing Business Units.
- Collaborate with Manufacturing, Quality, Engineering, Maintenance, IT, EHS, Purchasing, and Corporate teams.
- Provide technical guidance to resolve complex operational and project-related issues.
- Support client initiatives by ensuring adherence to Project Management processes and governance.
REQUIREMENTS & QUALIFICATIONS
Required
The assigned resource must meet the following minimum qualifications:
- Bachelor’s degree in Engineering, Computer Science, Information Systems, or related field.
- Minimum five (5) years of experience in pharmaceutical operations or manufacturing environments with proven project management experience, of which: o At least four (4) years must be in process automation within a pharmaceutical environment o At least two (2) years must be in computerized systems validation (CSV).
- Demonstrated proficiency in computer system lifecycle concepts, change control processes, and FDA regulatory requirements, including 21 CFR Part 11.
- Proven experience developing and reviewing Computerized Functional Requirements (CFR/URS) and Design Specifications (DS/FRS).
- In-depth knowledge of the design, installation, commissioning, and qualification of computerized systems, PLCs, and automation platforms in pharmaceutical manufacturing.
- Broad knowledge of cGMPs, FDA, EMA, and applicable regulatory guidelines for biopharmaceutical manufacturing facilities.
- Experience supporting internal and external regulatory audits (e.g., FDA, EMA). Strong understanding of pharmaceutical manufacturing processes, equipment, and automation systems.
- Knowledge of electrical controls theory, mechanical concepts, and electronic circuitry, with ability to read and interpret electrical and mechanical drawings.
- Proven skills in project management, systems development, and implementation of manufacturing automation, MES, and quality-related systems.
- Experience with PLC programming platforms, data acquisition systems, historians (e.g., OSI PI), databases (e.g., MS SQL), and industrial networking infrastructures.
- Ability to review and support development of SOPs and work instructions.
- Strong analytical and problem-solving skills, with ability to resolve complex technical issues based on data.
- Fully bilingual English/Spanish, written and verbal.
- Strong interpersonal skills with ability to work effectively across all organizational levels and disciplines.
- Ability to manage and prioritize multiple complex activities simultaneously.
- Self-starter, well organized, flexible, and able to meet deadlines.
- Willingness to work irregular hours, weekends, and holidays as required.
- Ability to exercise good judgment.
Preferred
- Experience with CMMS systems (e.g., Maximo).
- High level of expertise in Rockwell Automation platforms.
- Experience with Siemens, Wonderware, and FactoryTalk Batch.
- Experience with virtualization platforms (VMware vSphere).
- Experience with MES systems (e.g., Syncade).
- Experience with OSIsoft / AVEVA PI systems and Microsoft SQL databases.
SKILLS
Technical Skills
- PLCs, HMI, SCADA, DeltaV, FactoryTalk — advanced configuration and troubleshooting
- MES systems — support and integration
- Change control execution and CAPA support in regulated environments
- Automation procedure development — SOPs, security plans, backup/restore, disaster recovery
- cGMP, 21 CFR Part 11, and Data Integrity compliance
- Quality event investigation and internal audit support
- Network configuration and industrial communication protocols
- Microsoft Office 365
Soft Skills
- Deep technical ownership of automation systems
- Clear communication with Manufacturing, Quality, IT, and Engineering teams
- Proactive risk identification and escalation
- Disciplined in regulatory documentation and change management
- Project milestone accountability
- Consulting mindset — advising on technology use and process improvement
