Manufacturing Engineer

Bio-Techne; Harvard (MA); On-site; USD 58,000 - 96,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Short-term disability

Long-term disability

Pet insurance

Identity protection (ID Shield)

Job summary

Bio-Techne is seeking a Manufacturing Engineer to plan, design, and maintain manufacturing processes ensuring systems run per specifications and produce quality products.

The role involves determining parts and tools, developing process documentation and validations to regulatory standards, and collaborating with Formulation & Filling, Packaging, Materials, QA, and R&D to meet project deadlines.

Qualifications

• Bachelor's degree in Engineering or related field.
• 1–2 years hands-on experience in a regulated manufacturing environment preferred.
• Strong verbal and written communication skills required.
• Good understanding of cGMP and validation preferred.
• Strong organizational skills required.
• Solid mechanical and electrical skills.

Responsibilities

• Generate 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 transitioning to manufacturing.
• Troubleshoot manufacturing equipment and implement ECOs.
• Research, design, and procure process and packaging equipment.
• Qualify suppliers and materials; generate validation protocols and ECOs.
• Collaborate with QA on root cause analysis for CAPAs/Complaints and corrective actions.
• Create material specifications for new parts.
• Manage multiple projects with minimal supervision and meet deadlines.
• Adhere to safety policies and company procedures.

Skills

Verbal communication

Written communication

Project management

Analytical thinking

Education

Bachelor's degree in Engineering

Tools

cGMP knowledge

Validation protocols

Job description

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Pay Range

$58,300.00 - $95,800.00

Position Summary

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.

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.

Qualifications

• A Bachelors degree in Engineering or related field is required.
• A minimum of 1-2 years hands on working experience in a regulated manufacturing environment is preferred.
• Strong verbal and written skills are required.
• Good understanding of cGMP and validation is preferred.
• Strong organizational skills are required.
• Individual must possess strong mechanical and electrical skills.

Minimum Physical Requirements

• Remain seated in a normal position for extended periods of time up to 8 hours
• Walk, stand, and move for prolonged periods in a workday
• Reach up and out with hands and arms
• Talk and hear, verbally express information
• Keyboard, 10 keys,
• Repetitive motion; hands, arms
• Lift up to 25 pounds and carry a distance of 10 feet
• Use hands to grasp, hold, move and pickup objects continuously
• Ability to stoop or kneel for limited amounts of timeAbility to climb ladders
• Occasionally push/ pull up to 200 lbs a distance of up to 100 feet
• Able to spend time in cleanroom, walk-in refrigerators, and areas of increased noise level

Why Join Bio-Techne

• We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
• We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
• We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
• We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Bio-Techne is an E-Verify Employer in the United States.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.

This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact [e-mail] for assistance.