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Sr. Manager, Engineering

Company: AGC Biologics
Location: Boulder
Posted on: June 20, 2022

Job Description:

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 Senior Manager, Engineering manages a team comprised of Automation, Process, Reliability and Utilities Systems Engineers. This position is responsible for equipment performance, reliability, cost reduction/improvement, waste reduction, downtime reduction, as well as ensuring compliance with established policies, procedures and industry standards. This position manages internal resources in the above stated areas, works with vendors and consultants as required, and participates as an active member of the site Engineering Leadership Team. Further accountability for scheduling, training, mentoring and performance appraisals of staff. This position will report directly to the Site Head of Engineering and will be a leadership role within the organization.Principal Responsibilities

  • Manage direct reports and provide leadership and guidance for their professional and personal development.
  • Ensure information flow, problem-solving, goal setting, performance evaluation, and process improvements by coaching, empowering, and supporting the engineering staff in a High Performance Work System (HPWS) environment.
  • Assess and build technical capability staff.
  • Initiate design changes and modifications to improve Process Reliability, meet cost reduction goals and reduce dependencies on manual labor on an on-going basis.
  • Accountable for the development and implementation of effective preventive maintenance programs and appropriate spare parts procurement & inventory control.
  • Own and drive safety programs to ensure personnel are in compliance with federal/state and company policies and procedures.
  • Develop positive partnerships with other operational functions and suppliers to ensure human capital, equipment, production and sanitation processes are used in the most effective/efficient manner to meet or exceed manufacturing targets.
  • Drive EHS and GMP compliance to ensure a successful compliance/safety culture.
  • Achieve sustainability goals around utilities and waste streams.
  • Coordinate the selection, design and layout of biological manufacturing equipment.
  • Prepare, review, and approve vendor scopes of work and proposals.
  • Manage client expectations efficiently, with minimal guidance, while maintaining strong working relationships with all client representatives.
  • Ensure fiscal accountability
  • Develop/maintain team dashboard.
  • Manage/resolve planning and scheduling conflicts.
  • Assess resources required and resolve cross-functional conflicts.
  • Develop objectives working with user requirement and business plans.
  • Communicate issues or risks in a timely and effective manner; develop contingency/mitigation plans to address/resolve complex issues.
  • Drive operational excellence and continuous improvement.
  • Other duties as assigned by AGC Biologics. Knowledge, Skills & Abilities
    • Demonstrated deep understanding of cGMP Manufacturing and FDA regulations.
    • Demonstrated experience providing leadership and oversight in a highly regulated or pharmaceutical and/or biotech facility.
    • Demonstrated proficiency in computer software applications such as SCADA, BMS and DeltaV.
    • Knowledge of current best practices, principles and standards of engineering.
    • Excellent written, verbal, and interpersonal communication abilities.
    • Demonstrated ethics, integrity, and sound professional decision-making skills/judgment.
    • Must demonstrate high energy level, enthusiasm, initiative, flexibility, and the ability to meet deadlines.
    • Knowledge of Quality by Design, Six Sigma or other operational excellence tools used to create efficient and high quality processes preferred.
    • Adaptable to a fast paced, shifting work environment, willing to remain flexible to accommodate changing business conditions, work requirements and scheduling needs.
    • Strong analytical and problem solving skills.
    • Hazard Analysis and Critical Control Points (HACCP) certification strongly preferred.
    • Computerized Maintenance Management System; BMRAM a plus.Education/Experience
      • Bachelor's degree in Engineering/Biotechnology/related science; or equivalent combination of education and experience required.
      • A minimum of 10 years of manufacturing equipment maintenance experience with increasing levels of responsibility and authority or 8 years for MS candidates.
      • Minimum of 5 years in a management role.
      • Experienced working with plant systems such as: WFI, HVAC, Steam, Compressed air and Chilled water systems in addition to equipment like: reactors, stainless steel vessels, chromatography columns, etc.Compensation Range$129,500 - $155,400AGC 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.

Keywords: AGC Biologics, Boulder , Sr. Manager, Engineering, Engineering , Boulder, Colorado

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