Career Category

Job Description

This role will serve as a technical lead for the Chemical Synthesis API Manufacturing Facility in ASM for the facilities and engineering team. It will provide advance technical support/leadership to ensure the readiness of the equipment/ facility for successful introduction of new products in ASM. The role will be a liaison between corporate engineering and site operations in the design and implementation of new equipment and/or equipment modifications.

The Sr Engineer is overall responsible as an Equipment System Owner for Chemical Synthesis API process equipment as well as provide technical support to day-to-day manufacturing activities.

This role will partner with vendors/networks to determine innovative opportunities to improve the site’s reliability, efficiency, agility and differentiation.

The role will be a liaison between manufacturing, maintenance, engineering and automation in the troubleshooting and resolution of equipment related issues.  Experience in design, qualification, operation, maintenance and improvement of Chemical Synthesis API process equipment will be required to support day to day manufacturing activities as well as to lead improvement projects. Overall Chemical Synthesis processes knowledge will be required to perform complex troubleshooting activities. This role is crucial for Amgen’s success and it will be a key contributor in the ASM- Chemical Synthesis API Manufacturing Facility.

SPECIFIC RESPOSABILITIES INCLUDE BUT ARE NOT LIMITED TO:

New Product Introduction:

Provide technical expertise in site selection assessment to identify equipment/facility gaps, select new equipment, assess layout/utilities capacity and partner project managers to develop project cost and schedule. Lead F&E to participate in technical transfer activities and cross-functional meetings:

Make a batch (MAB) assessments

Equipment/instrument capability assessments

Collaborate with Automation and Process Owners (PO) to ensure automation procedures are available for use (including participation in wet testing)

Collaborate with Process Development (PD) and PO to ensure process risk are adequately evaluated

Collaborate with Supply Chain to ensure Single Use Components are delivered on time

Collaborate with PD and Validation to deliver cleaning method/validation

Particiapate in PSSR

Work closely with system owners to introduce new single use assemblies

Design & Project Engineering:

Work closely with project managers to introduce new equipment including development of business case, project charter, user requirement specifications, quality risk assessments, conceptual design, preliminary design, design specifications and detail design. Participate in design review and setup up of new asset and associated maintenance plan/spares in Maximo. Participate in commissioning and qualification experience activities such as protocol/report review and approval, FAT, SAT, PSSR, automation checkouts and IOQ.   Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications. Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.                                                                                               Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.

Innovation:

Provide technical expertise to assess emerging industry trends and partner with vendors/networks to determine innovative opportunities to improve reliability, efficiency, agility and differentiation. Continuously improve Business Intelligence capabilities (e.g. ability to extract, manipulate, analyze and trend performance data). Benchmark equipment performance (e.g. reliability, productivity) and determine improvement plans. Assess predictive technologies for implementation.

Orgainzation Leadership

Provide oversight of Process Equipment System Owners in chemical synthesis API manufacturing facilities Coach and mentor engineers to develop their technical competency and leadership skills

** Other functions may be assigned

Qualifications

Basic Qualifications

• Master’s degree in Engineering discipline and 6 years of directly related experience

  OR

• Bachelor’s degree in Engineering discipline or and 10 years of directly related experience

  Preferred Qualifications/Competencies:

• Leadership experience in managing process engineering team primary in chemical synthesis API manufacturing.
• Established expertise in at least 3 separate areas of engineering technology such as equipment design/operation/maintenance, automation, process engineering, project management and/or validation.
• Working knowledge of biopharmaceutical processes such as inoculation, bioreactors, harvest, chromatography, buffer / media tanks, viral filtration, tangential flow filtration, single use technologies and critical utilities will be added advantage.
• Knowledge in Automation systems and processes such as RD’s, Delta-V, BMS, ladder logic and PLC.
• Experience in validation processes such as generation/execution of Installation/Operation/Performance qualification documentation.
• Demonstrated project management skills (schedule/cost development, facilitation, collaboration, basic project management, completion and follow-up) and application of concepts.
• Ability to handle multiple projects at the same time, to delegate and manage the project work of others.
• Working knowledge of financial analysis tools.
• Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
• Ability to independently determine when additional resources are required to solve problems.
• Demonstrated skills in the following areas:
  • Dealing with and managing change.
  • Analytical Problem Solving.
  • Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS).
  • Conflict Resolution
  • Leadership and team building
  • Schedule and resources loading development

• Foster and maintain relationships with key site and network stakeholders
• Good communications skills, both oral and written, including presentation skills
• Interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met.
• Strong analytical skills and knowledge of industry trends to identify potential improvement opportunities.
• Ability to combine technical problem-solving skills with business acumen to determine best business solution.
• Knowledge of Operational Excellence practices such as lean manufacturing and lean maintenance.
• Management of contractors and vendors.
• Flexibility to work off-hours.