Posted: 11/06/20232023-11-062023-12-07Employment Type:Direct Hire/PermJob Category:EngineeringJob Number: 575469Is job remote?: NoCountry: United States
Job Description
Principal Engineer – (Full-time) – Onsite – Florida or New York
Global Medical Device organization seeks a Principal Automation Engineer for a full-time onsite role in New York or Florida. The ideal candidate will have 12 years of experience working within a medical device, GMP setting to develop, integrate and manage the automation manufacturing process control systems to include PLCs, SCADA, HMIs, motion control, robotics, historians, machine vision, OEE and MES systems. This person should have extensive Process and Packaging equipment design and operations, OEE improvements, and project management, and also identification and execution in Aseptic manufacturing and more. The ideal candidate will also have expertise within Sterile GMP Guidelines, EU Standards, Data Integrity Regulations and GAMP5 validation. Lastly, this person will have a BS in Electrical/Mechanical Engineering or similar area. Controls Automation and Validation process knowledge are a must have. This opportunity requires US Citizen or Green Card work authorization and provides competitive base compensation, bonus, and benefits within an onsite role based in northern NY or FL. Relocation is available.
Benefits:
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.
Responsibilities:
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.
Requirements:
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.
Candidate must reside or be willing to relocate for an onsite position in either northern NY or FL.
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the recruiter to ensure it’s from @planet-technology.com - and not a domain with an alternative extension like .net, .org or .jobs. Candidate safety is a top priority at Planet Technology.
Planet Technology and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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