Engineer (Biotech)

4 weeks ago


boston, United States Regulatory Connect Full time

Job Title Engineer (Biologics)


Location - MA

Contract


We are seeking a dynamic and motivated Process Engineer to join our clients team. In this role, you will lead critical manufacturing process initiatives, driving process efficiencies and quality improvements. If you have a passion for biologics or antibody drug conjugation manufacturing and thrive in a fast-paced environment, we want to hear from you.


**Key Responsibilities:**

- Lead projects focused on improving manufacturing processes, increasing yield, reducing cycle time, and driving cost reduction.

- Utilize statistical process control methodologies to gather and analyze process data. Develop action plans to enhance process robustness, prevent product loss, and control quality.

- Provide technical support to resolve shop floor issues, ensuring smooth operational workflows.

- Lead structured investigations to identify root causes of process issues and develop scientifically sound recommendations.

- Collaborate with cross-functional teams on site initiatives such as continuous improvement, capacity increases, and process remediation.

- Manage small to medium-sized projects, including project coordination, reporting, and team communication.

- Lead process validation efforts for operational changes, new materials, or technologies.

- Maintain up-to-date product and process documentation, ensuring compliance with internal procedures and regulations.

- Support regulatory audits by providing technical expertise and documentation.

- Champion EHS performance and compliance through active participation in EHS programs.


**Qualifications:**

- BS or MS in Chemistry, Biology, or Engineering (Chemical, Mechanical, Bio-chemical).

- Relevant technical experience in Process, Manufacturing, or Project Engineering.

- Strong knowledge of biologics or antibody drug conjugation manufacturing processes.

- Excellent problem-solving skills and experience with continuous improvement methodologies.

- Strong written and verbal communication skills in English.

- Experience with statistical process control and technical writing.


**Scope of Work:**

- Provide technical support on the shop floor and contribute to the execution of experimental and validation runs.

- Gather and analyze process data to develop action plans for process improvements and quality control.

- Maintain compliance by ensuring all process documentation is up to date and aligned with regulatory standards.

- Prepare reports and documentation for regulatory agencies, including Annual Product Reviews.


**Capabilities:**

- In-depth knowledge of biologics and ADC manufacturing.

- Strong problem-solving and project management skills.

- Technical writing proficiency for scientific reports and documentation.



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