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.