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Senior Automation Engineer

LSNE Contract Manufacturing
Bedford, NH
  • Posted: over a month ago
  • Full-Time
Job Description

Thrive in the dynamic and challenging environment of a contract development and manufacturing organization. Driven to excel through self-leadership and thriving team engagement. If this describes you, then look no further than LSNE. We have the experience, expertise and a successful track record in completing development of life-changing pharmaceuticals and medical devices. Together with our clients, we work to bring about treatment of many forms of cancers, Diabetes, communicable diseases, and many other illnesses. Come make a difference. Your work will matter and your contributions will be significant in these endeavors

We offer a competitive compensation and benefits package and a very generous paid time off benefit.

Join our team!

Senior Automation Engineer

Location: Bedford, NH

Designing Intelligent Capacity and Increased Efficiencies Through Systems Automation!

As the Sr. Automation Engineer, you will have ownership and accountability by ensuring manufacturing facilities are maintained inspection ready, and equipment and systems are always kept in a validated state.

With your expertise in Automation, you will have significant accountability to bring online two brand new manufacturing facilities as a automation engineering SME and will work closely with engineers managing the construction aspects of the new plants.

As a quality minded automation engineer, you will focus on operational effectiveness and excellence by designing the proper models for monitoring performance, provide input in the development of the automation road map for the next 5 to 10 years imbedding sustainability through staff knowledge, team capacity and learning how to draw from team members expertise for continuous improvements.

You will be working with the latest lyophilizing technology used at our manufacturing facilities, and work with innovative software which optimizes and increases the capabilities of those utilizing system data for their specific work disciplines of Quality, Validation, MTS and Facilities/Engineering.

You will work with and interact management at various levels within the organization as well as cross functional teams.


JOB DUTIES -

  • Develop and edit engineering design documents, technical evaluations, and test plans for cGMP process equipment, utilities and follow GAMP 5 and LSNE Data integrity guidelines.
  • Participate in Control System initiatives such as Change/Project Implementation, Incident/Issue Investigation & resolution, CAPA & Safety related corrective actions and manufacturing support. Participate in Control System initiatives such as Change/Project Implementation, Incident/Issue Investigation & resolution, CAPA & Safety related corrective actions and manufacturing support.
  • Support the operation of all GMP and non-GMP systems and other auxiliary equipment
  • Support all GMP and non-GMP systems and other auxiliary equipment with Programmable Logic Controllers (PLC's).
  • Take leadership during the entire life cycle of automation projects, from concept to feasibility and from fabrication and test to production. Design and document new test methods to measure equipment performance.
  • Manage critical automation projects through the entire project life cycle and ensure systems are maintained in a validated state after going live.
  • Work hand in hand with Facilities, Engineering, and Operations teams to support projects and operational needs.
  • Develop and manage design standards for our automation platforms.
  • Implement, maintain, and optimize automated platforms for the commercial and research laboratories.
  • Provide configuration, development, and break/fix day-to-day support of automation systems.
  • Lead automation system documentation, prepare technical and user documentation, and conduct system training.
  • Lead system maintenance and manage automation life cycle (review application patching, document test plans, and execute test scripts). Prepare RFQ's and solicit quotations from automation suppliers.
  • Design the layout of equipment and workspace for maximum efficiency and safety.
  • Design and engineer moderate and complex automation equipment, tooling and applications.
  • Prepare RFQ's and solicit quotations from automation suppliers.
  • Evaluate supplier quotations to determine the best combination of technical solution, cost and timing.
  • Develop budget, schedule for projects, and manage projects to stay within them.
  • Conduct equipment design reviews and provide design guidance to suppliers and status reports.
  • Provide on-site support during machine build, debug and testing/qualification.
  • Supervise installation and testing to verify requirements and specifications are met.
  • Develop manufacturing solutions with the best combination of manual, semi-automation and/or full automation.
  • Support new product development automation needs, facilitate assembly processes through the implementation of assembly cells and automated equipment at NPI stage and ensure meeting development timeline.

PROFESSIONAL SKILLS -

  • Able to prioritize and drive to results with a high emphasis on quality and to integrate and apply feedback in a professional manner.
  • Take leadership during the entire life cycle of automation projects, from concept to feasibility and from fabrication and test to production. Work both independently and in a team environment at all levels of the organization.

EXPERIENCE -

  • 10+ years' experience in a regulated environment (e.g., FDA).
  • Manufacturing engineering experience, working with automated manufacturing processes.
  • Experience coding/configuring in process controls (Control Studio, Batch, etc.).
  • Experience working with PLC and HMI applications (including RSlinx, RSlogix5, 500, 5000, & Factory Talk View).
  • Experience with FactoryTalk software and applications.
  • Experience integrating/interfacing equipment to control systems via OPC, Ethernet IP, etc.
  • Experience with OSISoft Pi Historian and MES. Control panel and automation hardware design experience.
  • Demonstrated knowledge of 21CFR Part 11, Annex 11, and GAMP5.EDUCATION -A Bachelor of Science degree in Computer Science, Chemical, Electrical or Mechanical Engineering.This position requires a high level of attention to detail along with the ability to develop a strong understanding of Equipment design standards

QUALITIES -

  • This position requires a high level of attention to detail along with the ability to develop a strong understanding of Equipment design standards

PHYSICAL REQUIREMENTS & MENTAL DEMANDS
  • Requires working in an industrial manufacturing environment including gowning.
COMMUNICATIONS & CONTACTS
  • Interacts with all departmental staff. Works closely with EHS, Engineering, Operations, MTS, Quality, Facilities, and Validation.

MANAGERIAL & SUPERVISORY RESPONSIBILITIES -
  • N/A

TRAVEL - < 10% or >15%

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.



Job Posted by ApplicantPro

LSNE Contract Manufacturing

Address

Bedford, NH
03110 USA

Industry

Manufacturing

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