Manufacturing

Senior Manufacturing/Validation Engineer – Medical Devices
Multi-national product manufacturer is seeking a talented engineer with 4-10 years of experience in the design, development and optimization of highly automated manufacturing lines. The selected candidate will have visibility and opportunity to make significant contributions to this growing organization.  This fulltime/direct role will work in conjunction with a small team of talented engineers as they bring on new manufacturing lines.

Duties:Responsible for engineering activities related to the production process with a focus on validation.

Support validation activities around Automated Manufacturing Equipment (AME) as it relates to process and software validation.

Lead continuous improvement, risk management, and process development of new and existing production equipment.

Accountabilities:
- Lead process mapping and continuous improvement activities of production line.
- Provide statistical analysis of production operations.
- Establishes operating parameters, ensures that processes operate within these parameters, and changes parameters as required to ensure products are manufactured within control limits and/or specifications.
- Serve as a member of the equipment validation team.
- Prepare and update standard operating procedures for equipment as necessary.
- Instruct and train employees per established guidelines.
- Ensure compliance with government regulations such as cGMP, OSHA, etc.
- Participate in engineering/production functions to achieve overall objective of the plant.
- Ensure the targeted volume of products is produced within budget while maintaining high standards of quality, safety and housekeeping.

Keywords: Process, manufacturing, validation, SPC, continuous improvement, six-sigma, equipment, packaging, parts, FDA, cGMP, medical device, sterile, aseptic, clean room, P&ID, IQ/OQ, process mapping, controls, PLC

CLICK HERE TO APPLY or call Kane Partners at 215-699-5500