Sr. Staff Engineer - Polymer Biomanufacturing

Becton Dickinson Medical Devices•Woburn, MA

3d•Onsite

About The Position

The Sr. Staff Engineer, Polymer Biomanufacturing provides technical leadership for BD’s P4HB polymer production and related biomanufacturing activities, supporting reliable GMP production, supplier oversight, validation, and continuous improvement.

Requirements

Knowledge of microbial fermentation, microbial product extraction and purification, GMP manufacturing environments, and product analysis.
Experience with vendor qualification and contract manufacturing is essential.
Master’s degree or higher in chemical engineering, biochemical engineering, biology, microbiology, polymer science, biomaterials, or a related technical discipline required.
Minimum of ten years of relevant experience in polymer production, bioprocessing, biomaterials manufacturing, or related regulated manufacturing.
Experience with GMP or quality-system-controlled manufacturing performed by external suppliers or contract manufacturers.
Experience with supplier qualification, validation, change control, deviations, batch record review, lot release, and technology transfer.
Experience working with cross-functional teams in R&D, Quality, Supplier Quality, Regulatory, Procurement, Materials, Manufacturing, and external suppliers.
Strong technical judgment and troubleshooting skills across complex production processes and suppliers.
Ability to translate technical information into clear procedures, specifications, risk assessments, training, and quality documentation.
Strong project management, communication, organization, and prioritization skills.
Ability to influence cross-functional teams without direct authority.
Strong understanding of GMP, quality systems, supplier quality, and regulatory documentation requirements.

Nice To Haves

Experience supporting medical device, pharmaceutical, biologic, or other regulated product manufacturing preferred.

Responsibilities

Manage approved vendors to schedule and oversee polymer production runs to meet production requirements.
Partner with Procurement, Quality, Supplier Quality, Regulatory, R&D, Manufacturing, and external suppliers to forecast future production needs and support continuity of supply.
Provide technical leadership for P4HB polymer production, including fermentation, purification, testing, release, and troubleshooting.
Assess supplier deviations, nonconformances, OOS results, and process anomalies with cross-functional partners.
Coordination of multiple vendors, contract review, compliance documentation, data evaluation, and technical reporting.
Lead or support validation, supplier qualification, technology transfer, and change control activities.
Develop and maintain GMP/QMS documentation, including specifications, procedures, work instructions, risk assessments, and validation reports.
Monitor process and quality trends and lead improvements in robustness, efficiency, quality, sustainability, and supplier capability.
Support future polymer and biomaterials initiatives, including new suppliers, process modifications, and customized polymer attributes.