Director Engineering - AML 14 Drug Product

Juncos, PR, US
Oct 29, 2020
Required Education
Associate Degree
Position Type
Full time
Are you looking for a meaningful new opportunity to test and growth your leadership skills? We have an outstanding Director Engineering job opportunity to support AML14 Formulation and Aseptic Filling Organization! This is an excellent opportunity to seek a variety of challenges and responsibilities in support to our Drug Product Manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico site.

The department

The AML-14 Facility is the home of a best-in-class, multi-product Drug Product Manufacturing Operation that produces well over half of the company DP volume. We are a facility that highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a high-performance culture integrating cross-functional teams from across the site with the goal of achieving being the best drug product filling facility in the world.

The functional areas to be led are: Utilities, Process Maintenance, Automation and Equipment Engineering (System Owners). These areas support the AML-14 manufacturing operations (syringe filling, vial filling, formulation, component preparation, dispensing, thawing and environmental control). The role will also be responsible for additional engineering functional area support as required and other AML-14 initiatives like capital and departmental project teams, MES / EBR team, Quality, Process Development, Validations, IS, Regulatory and so on.

The Role

The Director Engineering will provide direction, management; planning and administration of Engineering and Maintenance resources to ensure all facility and production requirements are met. This role is critical for the success of the AML-14 Formulation and Aseptic Filling Facility daily operation!

Specific responsibilities include but are not limited to:
  • Responsible for leading, managing, and advising the Engineering and Maintenance functions which provide support for current Good Manufacturing Practices (cGMP) operations at AML14 Drug Substance Department.
  • Ensures Maintenance and Engineering functions are aligned with cGMP requirements and regulations.
  • Develops, implements, and leads all aspects of maintenance programs for cGMP equipment.
  • Ensures that procedures are in place for cGMP activities, and procedures are followed by area personnel and contractors.
  • Responsible for selecting and on-boarding qualified and experienced personnel.
  • Ensures personnel are trained and managed according to cGMP procedures and requirements.
  • Ensures that non-conformances are identified and reported to the Quality unit, documented and addressed per procedures and long-term permanent solutions are implemented on a timely manner.
  • Ensures that there are an adequate number of personnel to perform the functions in accordance with cGMP requirements.
  • Ensures that area staff are qualified for assigned roles and trained to perform assigned tasks.
  • Ensures that training records are maintained.
  • Alerts senior management of safety risks critical quality, compliance and supply risks.
  • Support Continuous Improvement initiatives, programs and projects, drives an Operational Excellence culture.
  • Responsible for planning, developing, and maintaining the department operating and spares parts budget.
  • Makes disciplinary decisions and ensures performance is managed in the team.
  • Responsible for the active integration of AMGEN Networks in order to have them deliver value to operations.
  • Increase overall operations reliability, drives the OEE & Changeover improvement plant programs.
  • Develop a strong pipeline of productivity increase projects.
  • Lead human error reduction initiatives and deliver engineering controls to resolve them.
  • Maintain Operations roadmap for the future capacity, capabilities and obsolescence equipment's.
  • Responsible for supplying high quality operations within compliance boundaries.
  • Lead preventive maintenance improvements to process and support equipment, systems, critical components and instruments.
  • Lead maintenance services to plant systems through the Maintenance Work Order Program.
  • Facilitate and coordinate the Manufacturing Department operations according to the company goals and production forecast.
  • Identify ways to improve the manufacturing process and lower the production costs.
  • Ensure the facilities are maintained consistent with federal laws and regulations.
  • Perform management responsibilities associated to development, coaching, mentorship of engineering associates, as well as the performance evaluation of direct reports.
  • Throughout subordinates, ensure that performance evaluations of engineering associates are conducted on time.
  • Perform other management responsibilities such as the development and management of the area budget.
  • Conveys clear objectives to the organization, can plan and prioritize actions to achieve them.
  • Eliminates barriers affecting organizational performance.
  • Gets results that have a clear, positive, and direct impact on business performance.
  • Sets realistic time frames for achieving strategic objectives.
  • Ensures others have the information, authority, and support needed to achieve objectives.
  • Allocates organizational resources in alignment with strategic plans and priorities.
  • Asks the right questions to stimulate critical thinking and help others accurately analyze complex situations.
  • Willingly makes tough decisions and difficult trade-offs on behalf of the organization.
  • Anticipates complex challenges the organization may face in the future.
  • Requires that organization-level decisions be based on data and sound reasoning.
  • Asks for and evaluates dis-confirming information when making decisions.
  • Orchestrates organizational resources and activities to accomplish objectives.
  • Commits resources to build a strong innovation portfolio and capitalize on new business opportunities.
  • Creates a culture that nurtures and rewards creativity and innovation.
  • Energizes the organization by clarifying the broader purpose and importance of the work.
  • Fosters a corporate culture that is equipped to handle change and transformation effectively.

Basic Qualifications - Education & Experience

Doctorate degree in Engineering and 4 years of combined plant engineering and/or direct manufacturing experience within the pharmaceutical, medical device and/or biotechnology industry

Master's degree in Engineering and 8 years of combined plant engineering and/or direct manufacturing experience within the pharmaceutical, medical device and/or biotechnology industry

Bachelor's degree in Engineering and 10 years of combined plant engineering and/or direct manufacturing experience within the pharmaceutical, medical device and/or biotechnology industry

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Beyond that, the preferred qualifications are:
  • Direct engineering and maintenance experience in aseptic filling equipment / processes and isolators
  • Good organizational and communications skills.
  • Experience with regulated environments (i.e. cGMP, OSHA, EPA).
  • Experience managing regulatory agencies interactions
  • Knowledge of staff relations with the ability to coach, mentor and counsel staff when needed.
  • Ability to deal with and lead change.
  • Knowledge of basic compensation system practices and methodologies.
  • Negotiating, Budgeting, Goal setting and Capacity Planning/Inventory skills.
  • Leadership and teambuilding skills.
  • Computer Knowledge (MS Word, Excel, PowerPoint, Maximo) Knowledge in lean six sigma tools and/or Lean Maintenance experience.
  • Continuous improvement mindset.
  • Ability to resolve conflicts, make disciplined decisions and handle multiple projects at one time.
  • Ability to handle multiple projects at one time.

The benefits

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical needs and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.