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 and cell and gene therapies.
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.
Summary The Sr.
Manager, Engineering is directly responsible for the management and execution of all Engineering related activities carried out on-site (process, capital projects, utilities and GMP equipment, etc.).
This includes but not limited to, the management of internal company resources, (assets, financial and personnel), external professional Engineering and other firms as part of the execution of equipment, facility or utility modification / upgrade, or expansion projects.
Principal Responsibilities Manage all support activities and functions necessary to ensure successful completion of Engineering project objectives.
Ensure all work carried out and equipment installed is safe, effective and in compliance with the appropriate industry standards.
Under minimal direction, manage and oversee Capital Projects involving the planning, design, reconfiguration or construction, and qualification of facilities, utilities and equipment.
Oversee and direct process engineering transfer and optimization activities to ensure robust technical capability of manufacturing equipment.
Ensure all company and site Engineering policies and procedures are adhered to.
Ensure all work undertaken is reflected accurately in up-to-date Engineering, Project and Maintenance information files.
Manage site activities necessary for successful execution of project(s) and ensure these are completed as necessary to tie in with the overall project execution.
Manage and resolve technical issues or changes arising throughout Engineering project life cycle(s) whilst ensuring the overall project objectives of scope, cost and schedule are adhered to.
Seek and retain approval for Engineering and facility designs from site; Manufacturing (who approve designs from a manufacturing operations perspective); Quality (who approve designs from a regulatory compliance standpoint) Ensure all facilities, utilities and / or equipment are handed over effectively to site User Departments and Maintenance personnel.
Proactively provide feedback into the site capital planning and execution processes.
Adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements (for example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.) Develop and implement equipment reliability improvement projects Complete technical review and evaluation of complex engineering processes Coach and mentor engineering colleagues Perform other duties as assigned Knowledge, Skills & Abilities Comprehensive technical knowledge of pharmaceutical equipment and plant design; Comprehensive equipment and plant control systems understanding (distributed control systems, local and high speed equipment control, building management systems); Experience with pharmaceutical industry standards and requirements (Minimum US GMP); Thorough knowledge of the validation process Proven expertise in planning/organization/execution of complex capital projects in a GMP environment.
Demonstrated experience in RCA process and helping teams solve complex issues.
Experience leading and developing a diverse engineering team consisting of project and process engineering functions.
Demonstrates a disciplined approach to making decisions that are based on data and facts and is consistent with Vision/Business Goals and Values Education/Experience Bachelor’s degree in Engineering (MS preferred) and a minimum of 10 years’ experience, including a minimum of 5 years of engineering management experience.
Pharmaceutical Experience required.
PMP or similar certification preferred.
Equivalent Education And Experience May Substitute For Stated Requirements.
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.