Amgen Careers – Director Engineering – AML 14 Drug Product

Job Description:

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.

Job Responsibilities:

• Support Continuous Improvement initiatives, programs and projects, drives an Operational Excellence culture.
• Ensures that procedures are in place for cGMP activities, and procedures are followed by area personnel and contractors.
• 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.
• 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.
• Responsible for selecting and on-boarding qualified and experienced personnel.
• Alerts senior management of safety risks critical quality, compliance and supply risks.
• Ensures that training records are maintained.
• Ensures that there are an adequate number of personnel to perform the functions in accordance with cGMP requirements.
• Develops, implements, and leads all aspects of maintenance programs for cGMP equipment.
• Ensures personnel are trained and managed according to cGMP procedures and requirements.
• Ensures Maintenance and Engineering functions are aligned with cGMP requirements and regulations.
• Ensures that area staff are qualified for assigned roles and trained to perform assigned tasks.

Job Requirements:

• Experience managing regulatory agencies interactions
• Direct engineering and maintenance experience in aseptic filling equipment / processes and isolators
• Good organizational and communications skills.
• Negotiating, Budgeting, Goal setting and Capacity Planning/Inventory skills.
• Experience with regulated environments (i.e. cGMP, OSHA, EPA).
• Ability to deal with and lead change.
• Knowledge of staff relations with the ability to coach, mentor and counsel staff when needed.
• Knowledge of basic compensation system practices and methodologies.
• Computer Knowledge (MS Word, Excel, PowerPoint, Maximo) Knowledge in lean six sigma tools and/or Lean Maintenance experience.
• Leadership and teambuilding skills.

Qualification & Experience:

• 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
• 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

Job Details:

Company: Amgen

Vacancy Type: Full Time

Job Functions: Engineering

Job Location: Juncos, PR

Application Deadline: N/A

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