Director Engineering - New Albany OH

Military Spouse Corporate Career Network • New Albany, OH

5d • Onsite

About The Position

In this role as a member of the AOH Engineering leadership team, the director will provide leadership, strategy, and tactical direction for the engineering and maintenance teams supporting the assembly and packaging lines in AOH 24/7 operation. This position reports directly to the Executive Director F&E and will manage a dynamic team whose responsibilities include engineering and maintenance. Key responsibilities include: Ensure safety of all personnel during plant operations and engineering activities Ensure that all staff are adequately trained and comply with all GMP standards and procedures Maximize staff productivity and the efficient use of available resources Maintain and improve plant capability and equipment reliability in partnership with plant leadership and other technical staff Leverage resources to support ongoing department capital project investment Identify areas of potential improvement, conduct analyses, recommend solutions, sponsor improvement projects, and implement as required Maintain and develop key performance indicators, supervise, assess, and develop staff, and ensure that all targets and milestones are completed on time and on budget Interface with a diverse Amgen internal network including AOH clients (plant and area directors and front-line managers), Facilities & Engineering leadership (Engineering and Automation), Engineering Technical Authority, Technology, Global Capital Project Management, Environmental Health and Safety, and Process Development Specific responsibilities include: Oversee a safe and compliant workforce working with a highly utilized commercial operations site Provide day-to-day, small project, and plant shut-down support Work with a diverse group of clients, technologies, and integrated systems in product development all in a GMP and highly regulated setting Manage partners and drive new business processes to ensure continuous and sustained improvements Ensure readiness and compliance for internal audits, external agency audits, and partner visits Present engineering plans, progress, and status updates to project stakeholders Review and approve proposed engineering designs, and equipment improvements and changes Perform administrative and oversight functions in approving proposals and expenditures Participate in the development of department expenditure requests and partner with the projects teams to define the best engineering solution inclusive of long-term equipment performance Deliver effective troubleshooting and timely response to reduce downtime Drive robust equipment reliability

Requirements

• Doctorate degree and 4 years of Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies experience OR Master’s degree and 8 years of Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies experience OR Bachelor’s degree and 10 years of Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies experience
• At least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Managerial experience may run concurrently with the required technical experience referenced above

Nice To Haves

• Typically, 12+ years of relevant work experience with 8+ years’ experience in an operations / manufacturing environment
• Typically, 10+ years’ experience with regulated environments (i.e. FDA/cGMP, OSHA, EPA) preferred
• Must have experience leading an engineering department in a regulated GMP environment
• Knowledge of GMP manufacturing equipment and their design and operational aspects
• Excellent organizational and administrative leadership skills
• Ability to work and influence locally and across Amgen’s network
• Ability to work in a highly dynamic organization with a demanding environment
• Must have excellent verbal and written communication skills, as well as the ability to actively, and cooperatively work with cross-functional teams
• Demonstrated team motivation, leadership, and mentoring/staff development skills
• Understand regulatory trends in the industry.
• Direct experience with FDA or equivalent regulatory body
• Ability to manage multiple resource demands and prioritization, assess project effectiveness, and efficiency and manage demand
• Proven ability to motivate staff and establish and communicate visions/missions
• Proven ability to delegate and manage the work of others
• Demonstrate a high degree of creativity, foresight, and mature judgment in anticipating and solving problems by translating data into actionable solutions

Responsibilities

• Ensure safety of all personnel during plant operations and engineering activities
• Ensure that all staff are adequately trained and comply with all GMP standards and procedures
• Maximize staff productivity and the efficient use of available resources
• Maintain and improve plant capability and equipment reliability in partnership with plant leadership and other technical staff
• Leverage resources to support ongoing department capital project investment
• Identify areas of potential improvement, conduct analyses, recommend solutions, sponsor improvement projects, and implement as required
• Maintain and develop key performance indicators, supervise, assess, and develop staff, and ensure that all targets and milestones are completed on time and on budget
• Interface with a diverse Amgen internal network including AOH clients (plant and area directors and front-line managers), Facilities & Engineering leadership (Engineering and Automation), Engineering Technical Authority, Technology, Global Capital Project Management, Environmental Health and Safety, and Process Development
• Oversee a safe and compliant workforce working with a highly utilized commercial operations site
• Provide day-to-day, small project, and plant shut-down support
• Work with a diverse group of clients, technologies, and integrated systems in product development all in a GMP and highly regulated setting
• Manage partners and drive new business processes to ensure continuous and sustained improvements
• Ensure readiness and compliance for internal audits, external agency audits, and partner visits
• Present engineering plans, progress, and status updates to project stakeholders
• Review and approve proposed engineering designs, and equipment improvements and changes
• Perform administrative and oversight functions in approving proposals and expenditures
• Participate in the development of department expenditure requests and partner with the projects teams to define the best engineering solution inclusive of long-term equipment performance
• Deliver effective troubleshooting and timely response to reduce downtime
• Drive robust equipment reliability

Benefits

• A 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
• Flexible work models, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree