Biomanufacturing Engineer

Job Summary

We are seeking a Biomanufacturing Engineer to support the design, optimization, scale-up, and operation of biological manufacturing processes. This role works cross-functionally with process development, quality, and operations teams to ensure the safe, compliant, and efficient production of biologic products (e.g., vaccines, biologics, cell/gene therapies, or animal health products).

Key Responsibilities

Support design, development, and optimization of upstream and/or downstream bioprocessing operations (fermentation/cell culture, purification, filtration, filling)
Lead or support technology transfer and scale-up activities from process development to commercial manufacturing
Troubleshoot manufacturing process deviations and drive root-cause investigations and corrective actions (CAPA)
Author and review batch records, SOPs, process validation protocols/reports, and other manufacturing documentation
Ensure manufacturing processes comply with cGMP, regulatory, and quality standards
Collaborate with Quality, Process Development, Facilities, and Automation teams on equipment qualification and process validation
Monitor and analyze process data to identify opportunities for yield, efficiency, and quality improvements
Support commissioning, qualification, and validation of new or modified manufacturing equipment and systems
Participate in continuous improvement initiatives (Lean, Six Sigma) to optimize manufacturing operations
Support regulatory inspections and audits as a subject matter expert on manufacturing processes

Required Qualifications

Bachelor's degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Biology, or a related field (or equivalent experience)
Experience in biomanufacturing, bioprocessing, or biopharmaceutical production environments
Understanding of upstream and/or downstream bioprocessing unit operations
Familiarity with cGMP regulations and quality systems in a regulated manufacturing environment
Strong technical writing skills for authoring manufacturing and validation documentation
Ability to troubleshoot and resolve process and equipment issues
Strong attention to detail and commitment to safety and compliance

Preferred Qualifications

Experience with specific modalities (mammalian cell culture, microbial fermentation, cell/gene therapy, vaccines)
Experience with process validation and technology transfer projects
Familiarity with manufacturing execution systems (MES), DeltaV, or other automation/control platforms
Six Sigma/Lean certification or process improvement experience
Experience supporting regulatory inspections (FDA, EMA, or other health authorities)
Prior experience in pharmaceutical, biotech, or animal health manufacturing

Core Competencies

Strong understanding of GMP manufacturing and quality principles
Cross-functional collaboration with Quality, Process Development, and Operations
Analytical and root-cause problem-solving skills
Ability to work in a fast-paced, regulated production environment
Clear written and verbal communication, including with auditors/regulators

Note: This is a general-purpose template. Tailor requirements (degree level, modality experience, years of experience) to the specific client role before posting.

Biomanufacturing engineers