AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

The Engineer I provides support for biotechnology manufacturing by generating supportive documentation and operational assistance of Right First Time manufacturing. Working under the guidance of multi-departmental staff, individuals in this role take part in process transfer, resolving technical issues, and providing documentation to Manufacturing and Quality Assurance staff. The Engineer I has a high degree of personal integrity and can work independently. The Engineer I continuously seeks subject matter experts’ knowledge and integrates that knowledge into MSAT processes.

Essential Job Duties/Responsibilities
 

• Supports upstream and/or downstream Drug Substance commercialization and new product introduction assuring process fit to plant achieving right first time manufacturing in accordance with FDA/EMA/ICH regulations/guidance.
• Lead root cause investigations, writing and completing Quality investigations and corrective actions, such as CAPAs, CRs, and Deviations
• Lead troubleshooting efforts in manufacturing operations. Provide technical leadership to Manufacturing and other departments associated with GMP operations.
• Support/Lead resolution of deviations, investigations, and process issues.
• Develops and maintains strong relationships with Process Development (PD), Manufacturing, Quality Control (QC), Quality Assurance (QA), Engineering (ENG) and Project management (PM) to support robust launch, commercialization and batch disposition.
• Drive continuous manufacturing improvements for greater ease of use by collaborating with end-users on their departmental needs including the establishment of metrics and KPI tracking.
• Route MSAT documentation through Quality Management Software, and ensure that required documentation is reviewed and approved by key subject matter experts in a timely manner
   

Skills
 

• Strong technical skills with an emphasis on applying the needs of end-users to manufacturing processes
• Strong collaborative skills with an emphasis on seeking the advisement and gaining the consensus of subject matter experts
• Strong analytical problem solving skills to support technical transfer of new products
   

Required

QUALIFICATIONS
 

• 0-3 years of relevant industry experience
• BS/MS in engineering
• Experience with GMP manufacturing or other scientific laboratories procedures
• Demonstrated proficiency with Microsoft applications
• Demonstrated proficiency in collaborating with various subject matter experts with effective communication skills necessary to interact with internal stakeholders
   

Preferred
 

• Experience with SharePoint
• Experience with Quality Management Software, such as TrackWise Digital
• Experience with Upstream and/or Downstream manufacturing operations and equipment
   

Compensation Range

$66,960 - $92,070

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance.

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Looking for more jobs near me. Find your favorite job now by visiting our jobs page.