Manufacturing Engineer

Bio-Techne • Devens, MA

46d • $58,300 - $95,800 • Onsite

About The Position

The Manufacturing Engineer assists in the plan, design, and maintenance of manufacturing processes. Ensure systems are running according to specifications in the production of quality product. Determine parts and tools required for Manufacturing to achieve their goals of producing quality products. Develop process documentation and validations that meet applicable regulatory standards. This position requires close collaboration with the Formulation & Filling, Packaging, Materials, Q.C. and R&D departments. The ability to set project schedules and meet appointed deadlines is required.

Requirements

• A Bachelors degree in Engineering or related field is required.
• Strong verbal and written skills are required.
• Strong organizational skills are required.
• Individual must possess strong mechanical and electrical skills.

Nice To Haves

• A minimum of 1-2 years hands on working experience in a regulated manufacturing environment is preferred.
• Good understanding of cGMP and validation is preferred.

Responsibilities

• Generate, develop, and execute validation protocols for manufacturing and packaging equipment.
• Develop and modify procedures to streamline processes and improve product quality.
• Participate in process development for new products being transferred to manufacturing.
• Hands-on Manufacturing equipment troubleshooting and diagnosis. Follow through with documented procedure changes and required ECOs.
• Research, design, specify, and procure required process and automated packaging equipment.
• Qualify and validate new suppliers and materials. Generate required validation protocols and Engineering Change Orders (ECO)
• Collaborate with Quality Assurance to complete root cause analysis for CAPAs/Complaints and implement corrective/preventive actions.
• Generate material specifications for new parts.
• Manage multiple projects w/minimal supervision. Maintain projects on a schedule to meet predetermined deadlines.
• Follows company policies and practices as outlined in the Handbook, SOPs and SWIs and as well as follows guidelines regarding safety as outlined in the safety program and in accordance to the job function.
• Manages time well and will put in extended time as needed.
• Willingness to accept changes in work from day-to-day within reasonable and expected boundaries.
• Perform other duties as assigned.

Benefits

• competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
• employee resource groups, volunteer paid time off, employee events, and charity drives
• an accrued leave policy with paid holidays, paid time off, and paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level