Engineer III, Manufacturing Sciences

Biogen; North Carolina; Hybrid; USD 90,000 - 135,000; Full time

Job summary

Biogen is seeking a Manufacturing Sciences Engineer III who specializes in single-use consumable raw materials for biopharmaceutical manufacturing. The role supports process optimization and regulatory compliance, working hybrid with on-site presence during inspections and audits.

You will serve as a technical point of contact for raw materials, lead investigations, and collaborate with suppliers to ensure material qualification and compliance with industry standards.

Qualifications

• Bachelor’s degree in a scientific or technical field is required.
• Minimum 2 years of relevant industry experience.
• Knowledge of polymer chemistry, single-use systems, and regulatory documentation support.
• Willingness to work on-site during critical activities.

Responsibilities

• Serve as technical point of contact for raw materials.
• Oversee supplier capabilities, control strategies, and material qualification.
• Lead investigations and troubleshoot material failures.
• Support extractables/leachables studies and regulatory compliance.
• Participate in industry forums and audits.

Skills

Polymer chemistry

Single-use systems

Regulatory documentation

Education

Bachelor’s degree in scientific/technical field

Job description

Role

Manufacturing Sciences Engineer III, specializing in single-use consumable raw materials for biopharmaceutical manufacturing, supporting process optimization and regulatory compliance.

Responsibilities

• serve as technical point of contact for raw materials, oversee supplier capabilities, control strategies, and material qualification;
• lead investigations and troubleshoot material failures;
• support extractables/leachables studies and regulations;
• and participate in industry forums and audits.

Requirements

• Bachelor’s degree in a scientific or technical field;
• minimum 2 years of relevant industry experience;
• knowledge of polymer chemistry, single-use systems, and regulatory documentation support;
• willingness to work on-site during critical activities.

Preferred

• engineering or chemistry degrees;
• hands-on experience with extractables/leachables and supplier change management;
• prior manufacturing or engineering experience supporting deviations, CAPAs, and regulatory filings;
• experience collaborating with vendors and external partners.

HighValue

• biopharma manufacturing, single-use technologies, extractables/leachables, support for GMP operations, global regulatory compliance, and vendor audits.

WorkSetup

hybrid with on-site presence during inspections and audits.