Manufacturing Engineer

Posted Yesterday
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Devens, MA, USA
In-Office
58K-96K Annually
Junior
Biotech
The Role
Supports the design, maintenance, validation, and improvement of regulated manufacturing and packaging processes. Troubleshoots equipment, develops procedures and material specifications, qualifies suppliers, and supports new product transfers. Collaborates with Quality Assurance on root cause investigations and corrective actions. Manages multiple engineering projects, schedules, equipment procurements, validation protocols, and Engineering Change Orders while ensuring compliance with cGMP and applicable regulatory standards.
Summary Generated by Built In

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 time

  • Ability to climb ladders < 5’ high

  • 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 [email protected] for assistance.

Skills Required

  • Bachelor's degree in Engineering or a related field
  • Strong verbal and written communication skills
  • Strong organizational skills
  • Strong mechanical and electrical skills
  • One to two years of hands-on experience in a regulated manufacturing environment
  • Understanding of cGMP and validation

Bio-Techne Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Bio-Techne and has not been reviewed or approved by Bio-Techne.

  • Healthcare Strength Medical and dental coverage are often regarded as strong, with core health benefits broadly available across U.S. roles. Day-one eligibility and comprehensive options are described as a relative bright spot even when pay sentiment is mixed.
  • Leave & Time Off Breadth PTO, paid holidays, paid parental leave, and volunteer time are emphasized alongside flexible scheduling. Work-life balance elements are seen as strengths relative to base-pay concerns.
  • Strong & Reliable Incentives Quarterly or semi-annual bonuses and eligibility for annual cash incentives add meaningful upside for many salaried roles. Structured plans such as a Management Incentive Plan reinforce predictability of variable pay.

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The Company
HQ: Minneapolis, MN
2,512 Employees
Year Founded: 1981

What We Do

Bio-Techne Corporation (NASDAQ: TECH) is a leading developer and manufacturer of high-quality purified proteins and reagent solutions - notably cytokines and growth factors, antibodies, immunoassays, biologically active small molecule compounds, tissue culture reagents, and cell and gene therapy workflow solutions including T-Cell activation technologies. Bio-Techne’s portfolio also includes protein analysis solutions, sold under the ProteinSimple brand name, that offer researchers efficient and streamlined options for automated Western blot and multiplexed ELISA workflow. These reagent and protein analysis solutions are sold to biomedical researchers, as well as clinical research laboratories, and constitute the Protein Sciences Segment. Bio-Techne also develops and manufactures diagnostic products including FDA-regulated controls, calibrators, blood gas and clinical chemistry controls, and other reagents for OEM and clinical customers. Bio-Techne’s genomic tools include advanced tissue-based in situ hybridization assays (ISH) for research and clinical use, sold under the ACD brand, as well as a portfolio of clinical molecular diagnostic oncology assays including the ExoDx®Prostate (IntelliScore) test (EPI) for prostate cancer diagnosis. These diagnostic and genomic products comprise Bio-Techne’s Diagnostics and Genomics Segment. Bio-Techne products are integral components of scientific investigations into biological processes and molecular diagnostics, revealing the nature, diagnosis, etiology and progression of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $714 million in net sales in fiscal 2019 and has over 2,200 employees worldwide.

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