Biotech Manufacturing Engineer: Process Validation & Quality

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

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.