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Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Job Responsibility:
Be responsible for the department capital portfolio and project management of small capital projects at the drug substance facility
Provide technical leadership to a team of manufacturing support engineers supporting commercial production operations with emphasis on Drug Substance bioprocessing equipment
Establish clear expectations and priorities to staff
Encourage a culture of continuous improvement, partnership, and knowledge sharing
Provide development opportunities, feedback, and actively listen to staff
Cultivate a culture of safety ensuring the well-being of all staff members and drive efforts to reduce safety risks
Provide technical support to troubleshoot, identify and resolve process and system issues as needed
Be knowledgeable about compliance and regulatory aspects for equipment validation, operation and maintenance
Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners)
Ensure all tasks and projects are accomplished in a safe manner
Employ Business Analytics to assess performance and identify improvement opportunities
Lead Sustainability Program Management of Multi-faceted, Cross-functional, Network Initiative
Collaborates with leadership to set strategy and business objectives
Foster and maintain relationships with key stakeholders
Establish balanced scorecard of strategic and operational key performance indicators (KPI) in line with industry best practices to monitor, trend and analyze equipment performance, sustainability and reliability programs
Ensure action plans are established to address performance gaps or opportunities
Communicate gaps and establish the proper escalation process to the stakeholders
Identify opportunities to optimize organizational efficiency
Leads engineering and contractor evaluation and selection process
Requirements:
High school diploma / GED and 12 years of Engineering and/or Project Management experience
Associate’s degree and 10 years of Engineering and/or Project Management experience
Bachelor’s degree and 8 years of Engineering and/or Project Management experience
Master’s degree and 6 years of Engineering and/or Project Management experience
Doctorate degree and 2 years of Engineering and/or Project Management experience
Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Nice to have:
Bachelor’s degree in chemical engineering or related technical field
5+ years’ experience in engineering in a manufacturing support environment with 3+ years’ experience in the Pharmaceutical or Biotechnology industries
Demonstrated people management/leadership experience
Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP and Production Services. Upstream unit operation experience such as bioreactor or harvest equipment
Familiarity designing, troubleshooting, and operating equipment used in cell culture manufacturing including disposable technologies
Experience with Tech Transfer, Process Design, and Commissioning & Qualification
Experience with validation and change control methodology
Direct experience with regulated environments (i.e., cGMP, OSHA, EPA) including detailed understanding of cGMPs
Excellent written and verbal communication skills
Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment
Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information
Demonstrated ability to lead and influence cross-functional teams and embrace a team-based culture
Familiarity with designing and operating equipment used in biopharmaceutical manufacturing
Demonstrated experience in applying Operational Excellence and Lean Manufacturing
What we offer:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible