Job Title: Industrial/Manufacturing Engineering Expert
Job Location: Danvers, MA
Job Duration: 12 months
Job Description:
We are seeking an experienced Manufacturing Engineer with a focus on automation equipment development, implementation and validation to join our Mobius Engineering Automation Team in Danvers, MA. Mobius Engineering is focused on the production of single-use biopharmaceuticals assemblies. This position is primarily responsible for providing innovative automated solutions to existing manual processes through collaboration with equipment suppliers and internal colleagues.
• Develop and write equipment documentation (i.e. VMP, URS, FAT, Equipment IQ/OQ/PQ, DOE, and SOPs) for appropriate equipment and systems within the guidelines of cGMP, internal policies and procedures.
• Review executed protocols and review / write final reports
• Perform equipment IQ/OQ/PQ and provide maintenance / troubleshooting support on automation equipment as required.
• Provide guidance for the safe installation, maintenance and troubleshooting of automation machinery and equipment.
• Work closely with operations to develop, coordinate, and implement technical training plans for employees.
• Train operators and Preventive Maintenance Technicians on new equipment and process.
• Develop, evaluate, improve and document mechanical assemblies used in the manufacturing processes.
• Design fixtures, tooling and conceptual mechanical layouts.
• Provide engineering support in operations to trouble shoot and resolve technical mechanical and electrical issues.
• Support company policies and procedures, goals and objectives, all regulatory and GMP requirements.
• Support LEAN initiatives as required
Who You Are:
• Minimum of 10-15 years of experience in definition, design, development and implementation of production control systems for an advanced technology facility.
• Experience in a commercial medical, biotechnology, Bio-pharmaceutical manufacturing environment is highly preferred.
• Ability to prioritize and work on multiple projects
• Able to self-direct toward individual milestones as part of team projects with a strong sense of responsibility, urgency, and high energy with a positive behavior.
• Must be a self-starter and work with minimal supervision
• Strong communication and interpersonal skills, ability to collaborate across disciplines
• Bachelor's degree in Mechanical, Manufacturing or Electrical Engineering.