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 an Engineering Technical Lead (ETL) to support manufacturing operations in a GMP-regulated environment. The ideal candidate will have a strong technical background in Packaging and Inspection equipment, with experience supporting manufacturing systems, troubleshooting, equipment implementation, and cross-functional engineering activities.RESPONSIBILITIES Technical Support: Provide technical engineering support for Packaging and Inspection manufacturing equipment.
- Troubleshooting: Troubleshoot and resolve equipment and process issues.
- Installation & Startup: Support equipment installation, commissioning, and startup activities.
- Cross-Functional Coordination: Coordinate engineering activities with manufacturing, maintenance, quality, and validation teams.
- Documentation: Review and update technical documentation, procedures, and drawings as required.
- Change Control & CAPA: Support change controls, investigations, and CAPA implementation.
- Compliance: Ensure compliance with GMP, safety, and site engineering standards.
- Reliability Improvements: Participate in equipment performance improvements and reliability initiatives.
- Technical Guidance: Provide technical guidance during maintenance, upgrades, and process optimization.
- Project Execution: Support project execution and engineering deliverables as assigned.
- Front-End Planning: Preparation of front-end planning documents.
- Design Leadership: Lead the design process.
- Value Engineering: Provide value engineering / creative problem solving.
- Sourcing Strategy: Participation in the development of the sourcing strategy for projects.
- Design Library Evaluation: Evaluate the design library against the project scope and issue relevant specifications or standards.
- Design Review: Review of the project plans for adherence to engineering standards and specifications.
- Deviation Management: Identification of possible deviations to specifications. Submittal and approval of variance.
- Loss Prevention: Ensure Factory Mutual loss prevention recommendations are issued and addressed in the design.
- EHSS: Ensure EHSS requirements are considered in the design.
- Discrepancy Resolution: Technical support during project execution and lead for discrepancies.
- Liaison Role: Liaison to engineering technical authorities, subject matter experts, consultants, and engineer of record.
- RFI / Submittal Review: RFI and submittal review process.
- Schedule Tracking: Track design progress against plan and ensure alignment with overall project's schedule.
- Change Management: Engineering change management.
- C&Q Support: Consultant to the commissioning and qualification work stream.
- Change Control Consulting: Consultant to the change control evaluation process.
- Vendor Point of Contact: Point of contact between equipment vendors and the site.
- Document Management: Establish method to manage information and documents. e-Builder preferred for capital projects.
- FAT Planning: Factory acceptance test planning.
- Equipment Readiness: Ensure project plans and details are fit to introduce equipment.
- Design Qualification Reporting: Develop, submit, and approve design qualification report (for level 1 systems). REQUIREMENTS & QUALIFICATIONS Required Bachelor's degree in Engineering. Preferred Civil, Electrical, or Mechanical Engineering discipline preferred.
- Experience managing capital projects, contractors, and reviewing designs is a plus. SKILLS Technical Skills Front-end planning and capital project design leadership.
- Technical engineering support for Packaging and Inspection equipment, including troubleshooting and process issue resolution.
- Design review, RFI, and submittal management aligned to engineering standards and specifications.
- Commissioning, qualification (C&Q), and change control support.
- Technical documentation, procedures, and drawing management in a GMP-regulated environment. Soft Skills Cross-functional coordination with manufacturing, maintenance, quality, and validation teams.
- Effective communication as liaison among technical authorities, subject matter experts, consultants, engineer of record, and equipment vendors.
- Value engineering and creative problem-solving.
- Strong organizational and schedule-tracking skills to manage multiple project deliverables.
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