Amgen

Director Engineering - AML6 Drug Substance

Employer
Amgen
Location
Juncos, PR, US
Posted
Nov 19, 2020
Ref
R-108211
Required Education
Associate Degree
Position Type
Full time
HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Director Engineering - AML6 Drug Substance

Live

What you will do

Let's do this. Let's change the world! In this vital role you 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-6 multi product Drug Substance operation!
  • Responsible for leading the facilities and maintenance engineering organization in support of the AML6 Drug Substance manufacturing facility.
  • Accountable for the building, maintenance of the facility and equipment, operation of critical utilities, facility sanitizations, and staff and equipment safety.
  • Ensures facility and maintenance organization is aligned with cGMP requirements and current global 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.
  • Selecting and on-boarding contracted personnel ensuring that there are an adequate number of personnel to perform the functions in accordance with cGMP requirements.
  • Ensures that area staff (regular and contracted) are qualified for assigned roles, and trained to perform assigned tasks.
  • Alerts senior management of critical quality, compliance, supply and safety risks.
  • Responsible for planning, developing, and maintaining the department facility and maintenance budget.
  • Responsible for the active integration into Amgen global networks in order to deliver value to the collective operations.
  • Responsible for supplying high quality operations within compliance boundaries.
  • Lead preventive maintenance to equipment, systems, critical components and instruments.
  • 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 and make disciplinary decisions.
  • Conveys clear objectives to the organization, can plan and prioritize actions to achieve them.
  • 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.
  • 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.
  • 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.
  • Fosters a corporate culture that is equipped to handle change and transformation effectively.


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Director Engineering professional we seek is a strong leader with these qualifications.

Doctorate degree in Engineering and 4 years of combined plant engineering and/or direct manufacturing experience within a GMP regulated industry
OR
Master's degree in Engineering and 8 years of combined plant engineering and/or direct manufacturing experience within a GMP regulated industry
OR
Bachelor's degree in Engineering and 10 years of combined plant engineering and/or direct manufacturing experience within a GMP regulated industry

AND

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:
  • 10+ years of experience in Pharmaceutical and/or Biotechnology industries, leading people and/or projects.
  • Direct experience in equipment maintenance and critical utilities operations.
  • Excellent verbal and oral communication skills (English and Spanish).
  • Good organizational and communications skills.
  • Experience with regulated environments (i.e. cGMP, OSHA, EPA).
  • Knowledge of staff relations with the ability to coach mentors and counsels staff when needed.
  • Ability to deal with and manage 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.
  • Experience with conflict resolution, making disciplined decisions and handling multiple projects at one time.


Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits


Apply now for a career that defies imagination, objects in your future are closer than they appear (careers.amgen.com)

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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.