Job Posting Location: Daytona Beach, Florida, United States
Functional Area: Other Areas
Working Model: Onsite
Days of Work: Wednesday, Tuesday, Thursday, Friday, Monday
Shift: 5X8
Relocation Available: Yes
Requisition ID: 11578
Position SummaryThe Engineering Specialist is responsible for supporting, optimizing, and improving automated equipment, control systems, and infrastructure within a regulated pharmaceutical and medical device manufacturing environment. This role serves as a technical subject matter expert (SME) for high-precision Form-Fill-Seal (FFS) and Kiefel-type thermoforming systems. The Specialist provides project and lifecycle support for systems and drives continuous improvement initiatives to ensure operational efficiency, compliance, and business continuity. This position leverages advanced engineering principles and Lean methodologies to maximize Overall Equipment Effectiveness (OEE) and minimize production scrap.
Key Responsibilities- Analyze existing equipment, processes, facilities, infrastructure, and systems to identify improvement opportunities and recommend solutions to optimize performance.
- Serve as a Subject Matter Expert (SME) for assigned systems and technologies, providing technical guidance and recommendations to maintenance and operations teams.
- Serve as the primary technical lead for Kiefel-type thermoforming and Form-Fill-Seal (FFS) applications, ensuring optimal machine synchronization and station alignment.
- Anticipate potential process risks, technical conflicts, and system issues; develop contingency plans to support business continuity.
- Troubleshoot, modify, and maintain automated equipment in compliance with Pharmaceutical and Medical Device GMP change control standards.
- Perform advanced troubleshooting and root cause analysis on servo-driven systems (e.g., IM1/IB1 nipper systems), thermal welding stations (WT1, WT2, WT3), and pick-and-place modules (TL1).
- Create, review, and update system specifications, technical documentation, and standard operating procedures (SOPs).
- Develop and standardize technical training tools, including One Point Lessons (OPLs) and Work Instructions (WIs) for critical machine adjustments (e.g., die gaps, nozzle depth, and bearing eccentricities).
- Train users and peers on supported systems and technologies to enhance site-wide technical competency.
- Support software and system lifecycle activities, including hardware/software upgrades, system retirement, and data integrity compliance.
- Lead scrap reduction and cost-saving initiatives through the optimization of Critical Process Parameters (CPPs), tooling precision, and material utilization.
- Design and implement custom jigs, fixtures, and replacement components using CAD software (AutoCAD, SolidWorks, or Solid Edge) to facilitate rapid changeovers and improve reliability.
- Perform mechanical reverse engineering of legacy tooling and components to ensure long-term equipment sustainability.
- Collaborate with vendor partners and external affiliates to evaluate and select appropriate technical products, upgrades, and retrofits.
- Monitor and audit equipment performance to ensure alignment with validation protocols (IQ/OQ/PQ) and quality standards.
This list is not exhaustive. Additional duties may be assigned as business needs evolve.
Qualifications Required- Bachelor's degree in Mechanical Engineering, Electrical Engineering, or a related technical discipline.
- 8+ years of related experience in automation engineering, manufacturing engineering, or systems engineering within pharmaceutical, medical device, or other highly regulated environments.
- Advanced proficiency in CAD software (AutoCAD, SolidWorks, and/or Solid Edge) for mechanical design and site layout updates.
- Demonstrated expertise in high-volume mass manufacturing, specifically with automated bag-producing machines or Form-Fill-Seal (FFS) technology.
- Lean Six Sigma Black Belt certification is highly preferred, with a proven track record of driving data-driven process improvements and scrap reduction.
- Strong background in CNC programming, tool and die maintenance, and precision fabrication techniques.
- In-depth technical knowledge of servo-driven motion control systems and high-precision thermal welding processes.
- Experience leading technical projects from conception through validation (IQ/OQ/PQ) and full operational handover.
- Ability to apply advanced engineering theories, concepts, and best practices to determine appropriate technical solutions for complex automation challenges.
- Works with minimal supervision, relying on experience and sound judgment to plan and accomplish goals.
- Strong problem-solving skills with the ability to resolve complex technical issues across integrated mechanical, electrical, and pneumatic systems.
- Effective communication skills with the ability to collaborate with supervisors, peers, and external vendors.
- Experience influencing technical decisions and supporting long-term continuous improvement strategies.
Occasional business travel required (approximately 10%).Occasional on-call Engineering Support (approximately 10%).This role is part of a broader engineering team responsible for supporting a 24/7 manufacturing operation. As such, the Engineering Specialist is expected to participate in a structured on-call rotation, providing after-hours technical support in collaboration with the engineering team to ensure continuous operations, rapid issue resolution, and minimal production disruption.
Valid driver's license and passport required.Physical DemandsWhile performing the essential functions of this role, the employee may be required to: Perform light work, including exerting up to 20 lbs of force occasionally and up to 10 lbs frequently. Sit, stand, walk, talk, and hear for extended periods. Use hands and arms to handle, feel, reach, push, and pull as needed.
Work EnvironmentModerate noise level. Work performed in both office and production/manufacturing environments. Frequent proximity to moving mechanical parts and automated manufacturing equipment.
Salary Range: $101,437- $126,789
