Sr. Manufacturing Engineer & Project Manager
1400 N Goodman St Tampa, FL 33592 US
Global Medical Device organization seeks a Sr. Manufacturing Engineer & Project Manager for a full-time onsite role in one of the above locations, for relocation or local candidates. This requires a minimum of 12 years of experience working within a medical device/GMP setting, having performed integrations and project management of automated high-volume low-cost manufacturing and process control systems. A history of managing and overseeing integrations of PLCs, SCADA, HMIs, motion control, robotics, historians, machine vision, OEE and MES systems is also required. Expertise in Process and Packaging equipment design and operations, OEE improvements, project management, identification, and execution in medical device or pharma is a must, with aseptic manufacturing expertise idyllic. Expertise within Sterile GMP Guidelines, EU Standards, Data Integrity Regulations and GAMP5 validation is required, along with project management in the development and deployment of capital assets and systems. PMI certification is a plus. Opportunity affords selected candidate an extremely competitive compensation/benefits and affiliation with an international name brand organization. Requires US Citizen or Green Card work authorization and is an onsite role requiring individual to be based, or willing to relocate in any of the above-mentioned areas. No 3rd party recruitment firms please.
- Competitive base compensation depending upon individual expertise.
- Medical Insurance to include FSA and HSA options.
- Dental and Vision Insurance
- Prescription Discount
- 401K with organization 100% match of first 3% employee contribution; 50% match of next 3% employee contribution.
- Employee Stock Purchase Plan – for every employ purchased share, .75 restricted stock unit granted; vested after 1 year.
- Up to 15% annual performance bonus; based on individual and company performance.
- Relocation based on candidate location and requirements.
- Performing extensive Project Management and Validation within a medical device manufacturing GMP regulated environment, while focusing on process and packaging equipment operation and design.
- Designing, Developing, and Implementing integrated and automated GMP systems and control software applications.
- Developing automated requirements for PLC / SCADA / MES controls hardware/software automation solutions for capital projects; ensuring integrated solutions for product line or capacity expansions are integrated according to GMP.
- Performing validation processes to include GAMP5 processes.
- Identifying new technologies and automated systems that could reduce manufacturing and material costs to improve efficiencies; develop business case and justification around these potential operations to present to leadership.
- Developing and implementing isolated OT environments to include network topologies and configuration to enable secure manufacturing systems.
- Providing technical and controls core competency support for manufacturing (within Product, Pharma and Surgical areas), operations and engineering.
- Partnering with global and domestic manufacturing sites to create/implement project schedules to ensure work is delegated and completed on time and within budget.
- Ensuring global/domestic manufacturing sites meet overall capital programs and goals.
- Overseeing technical solutions to proactively manage project scopes and customer expectations, while managing and approving scope changes as they come.
- Performing project management to include leading multi-disciplined, cross functional teams and delivering project objectives on time, within budget and within regulatory required standards, while providing project updates and properly setting expectations.
- US Citizenship or Green Card Work Authorization; No 3rd party agencies please.
- Required location near client site in areas listed prior; meaning open to candidates local or willing to relocate.
- BS in Electrical Engineering or similar; advanced degree is a plus.
- 12 years’ experience in the development, project management and integration of automated high-volume and low-cost manufacturing or process control systems.
- Prior systems expertise includes PLCs, HMIs, SCADA, Motion Controls, Historians, Robotics, Machine Vision, MES and OEE Systems Software.
- Other systems expertise required include SDLC methodologies, OT network infrastructure, statistical analysis, MS Project, AutoCAD, and SQL.
- A background in pharmaceutical or medical device manufacturing with a focus on managing process and packaging equipment operation and design projects.
- Expertise having performed OEE improvements (within the aforementioned areas), project identification, and execution within Aseptic Manufacturing Environment are highly desired.
- A history of working within Sterile GMP guidelines (or Aseptic), EU Standards, Data Integrity Regulations and GAMP5 Validation.
- Strong Project Management, Controls Automation, and Validation experience.
- Must possess excellent communication skills, as a self-directed project manager.
- An ability to work within a fast-paced, cross functional setting is required.