Associate Manufacturing Engineer

We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World. 

A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide. 

Position Summary

The primary role of the Associate Manufacturing Engineer is to provide advanced documentation, equipment, investigative, and process support to the manufacturing organization. The Associate Manufacturing Engineer will be the Technical Manufacturing representative on various projects and cross functional teams, will provide training, participate and/or lead in the implementation of new equipment and processes, author Change Controld, BOM, and SOP/MBR changes.

Duties & Responsibilities

• Authoring of equipment and facility change controls, MBR revisions, and CAPA Action Plans.
• Process and equipment support and troubleshooting.
• Author, revise and approve critical Manufacturing documentation, i.e. MBRs, BOM, and SOPs.
• Project validation support and execution.
• Seek out process inefficiencies and implement solutions.
• Development and execution of training materials for new processes and equipment in conjunction with the site technical training team.
• Support of MFG shift operations, Tech Transfers, Process Improvements, and other teams as required.
• Lead manufacturing process improvement projects and interact with cross-functional groups to achieve departmental and organizational goals.
• Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.

Education & Experience

• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
• Direct biologic manufacturing experience of 3+ years.
• Extensive knowledge of SOPs and GMPs and the know-how to work within a regulated environment.
• Strong knowledge of biopharmaceutical manufacturing processes.
• Adaptable to a fast paced, complex and ever-changing business environment.
• Effective verbal and written communication skills with technical writing skills.
• Proficiency in the use of computers and business software applications.

Knowledge, Skills, Abilities

• The position requires a strong understanding of cGMP and regulatory agency requirements and strong technical operational knowledge of the upstream and/or downstream operational unit.
• Incumbents must have demonstrated experience in solving complex technical issues in Biologics manufacturing, and have the skills and understanding to troubleshoot process equipment and the overall manufacturing process.
• The role requires demonstration of successful participation on diverse work teams where combined contribution, collaboration and results were expected.
• The position requires excellent written and verbal skills and the ability to provide direction and communicate expectations to the operating staff.
• The candidate will have strong computer skills and be proficient in the following programs: Word, Excel, Visio, and Project.
• The position requires the ability to work off-hours as needed to complete projects or key tasks requiring SME oversite.

Physical Demands

• Position requires repetitive use of hands and wrist (computer work), and infrequent lifting of items not to exceed 50 lbs.
• Occasional bending, twisting, and stooping to allow for gowning into classified environment.

Work Environment

• Position is primarily office based with occasional work in a classified GMP manufacturing environment.
• Position is a team and project-based position that will require occasional shift work, weekends and holidays.

Travel

<5% travel will be required for this position. 

Target Bonus

8%

Work Location:

East Syracuse, NY 

 

We are an Equal Employment Opportunity (“EEO”) Employer. 

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities!  If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!