Process Engineer I

LSNE Contract Manufacturing Bedford, NH
JOB SUMMARY

Responsible for designing and implementing manufacturing processes, equipment, and plants (from pilot to fully operational) to achieve the production goals of the organization. Identifies and develops process and equipment needed to produce specific products, parts, and components.

JOB DUTIES

* Supporting all operations from aseptic filling, formulation, medical device manufacturing (troubleshooting equipment, improvements etc) across LSNE

* Focus on various levels of PLC controls, panel design, ladder logic and upgrading control systems

* Support in the commissioning and supporting validation of new equipment

* Generation of critical spare parts list for cGMP equipment

* P+ID drawings, walk downs and Autocad drawings when needed

* Supporting scale up activities from R+D to production

* Sourcing new equipment and estimations

* Suggest improvements to processing and implementation to produce better quality products at higher yields

* Change Controls and Corrective Actions support

* Analyzing PLC controls and troubleshooting

* Calibration Support

EDUCATION, PREPARATION, TRAINING & EXPERIENCE

* Bachelors Degree or higher in Chemical, Mechanical or Electrical Engineering with 2-5 years of experience

* Experience with lyophilization and aseptic filling equipment preferred but not required

* Innovative and capable of developing alternative solutions to issues at hand

* Knowledge of GMPs, 21CFR, and other international regulatory requirements and guidelines

* Ability to read/interpret engineering drawings and design documents

* Familiar with PLC controls and Technologies

* Familiar with P+IDs and Process Flow Diagrams

* Experience using drawing programs

* Excellent technical writing, verbal communication, and presentation skills

* Must be people oriented and a team player

* Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio

PHYSICAL REQUIREMENTS

* Must be able to gown appropriately (don nitrile gloves, hairnet, facemask and Tyvek suits) and lift a minimum of 20 lbs.

* Frequent reading, writing, problem solving, verbal communication

COMMUNICATIONS & CONTACTS

* Interacts with all departmental staff.

* Works closely with Operations, Quality and Validation.

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.