Senior Manager Process Engineering

What youwill do

Letsdo this!Letschange the world! In this vital role you will oversee the engineering team lead technical projects and drive innovation in product design and manufacturing processes. You will solve complex engineering problemsoptimizeprocesses and ensure the companys engineering efforts align with strategicobjectives. You will also provide leadership and guidance to the engineering team supporting 24/7 manufacturing and facility operations.

The Senior ManagerProcessEngineering will join the Facilities & Engineering (F&E) groupreporting to the Facilities & Engineering (F&E)Directorpartnering closely with the corporate engineering team to design build commission and qualify new equipment and systems needed for drug substance production. This role will develop domainexpertiseto support operations upon start-up focusing onProcess engineering and plant equipmentas well as hiring and training the staff required to support startup and operations.

Key responsibilities include:

Sitedesignconstruction start-up and operational readiness:

• Execute and guide thecommissioning and qualification ofprocess equipmentin alignment with GMP requirements while working in partnership with global engineering during site installation. Ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery.

• Ensure systems are installedoperatingsafelyandcomplywithpertinentenvironmental health/safetypracticerulesand regulations.

• Perform engineering assessmentsforplant equipmentoperationsimplementing equipment modifications and supporting engineering runsin support of new product/technology introductions as.

Site Operations:

• Provide system ownershipforprocess equipmenttypically used in biologics manufacturing includingUpstream(Seed train production Bioreactors Harvest) andDownstreamPurification(e.g.Chromatography and viral Filtration skids UFDF) and CIP/SIPSkids.

• Lead a team ofProcessEngineeringprofessionals and serve as the main point of contact forProcessandequipment engineeringfunction.

• Establish clear expectations and prioritiestostaff. Encourage a culture of continuous improvement partnership and knowledge sharing.Providedevelopment opportunities feedback and actively listen to staff.

• Effectively collaborate with key customers and support groups (e.g.Manufacturing Quality Process Development Maintenance network partners).

• Work with original equipment manufacturers for breakdown and planned maintenance ofprocess equipment.

• Work with integrated service providers for day-to-day operational activitiesbreakdownand planned maintenance.

• Leadidentifyingand implementing engineering-based improvements or upgrades toprocessequipmentsystems.This may include developing business cases for improvementsidentifyingdesign requirements and translating these requirements intoprocessequipment/system design specifications and supporting the construction startup and validation of equipment.

• Develop equipment maintenance programs ensure the availability of spare parts andcoordinatemaintenance activities to ensure systems are in proper working order.

• Ensure plant readiness and quality and regulatory compliance for internal audits external agency audits and partner audits for theprocessequipment.

• Providesystem guidance toidentifyperformance risks and implement risk reduction strategies.

• Provide technical support to troubleshootidentifyand resolve process and system issues as needed.

• Provide strategictactical managementand leadershipto ensure24x7 day-to-dayreliability of plant operations.

• Participate in the budgeting process forprocess engineering including forecasting costs managing expenditures and ensuring efficient allocation of resources.

• 10% domestic/international travel

Win

What we expectofyou

We are all different yet we all use our unique contributions to serve patients. The collaborative individual weseekis a leader with these qualifications:

Basic Qualifications

• Doctorate degree and 2 years of engineering experience

OR

• Masters degree and 6 years of engineering experience

OR

• Bachelors degree and 8 years of engineering experience

OR

• Associates degree and 10 years of engineering experience

Or

• High school diploma / GED and 12 years of engineering experience

And

• 2 years of managerial experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation of resources

Preferred Qualifications

• Bachelors degree inChemicalorMechanical Engineeringor related technical field.

• 8yearsof relevant work experience with5 years experience in Biopharmaceuticaloperations/manufacturing environmentfocused onprocess andplantengineering function.

• Demonstratedpeoplemanagement/leadership experience.

• Direct knowledge of biopharmaceutical production facilitywith direct experience withUpstream(Seed train production Bioreactors Harvest) andDownstreamPurification(e.g.Chromatography and viral Filtration skids UFDF) and CIP/SIPSkids.

• Experience with Tech Transfer Process Design and Commissioning & Qualification.

• Experience working in a regulated environment (e.g.cGMP OSHA EPA etc.) experience interacting with regulatory agencies and inspectorsandfamiliarity with GMP quality systems/processes such as change control non-conformancescorrective and preventative actions and qualifications/validation

• Familiarity with designing and operating equipment used in biopharmaceutical manufacturing

• Independent ambitious organized able to multi-task in project environments and skilled incommunication facilitation and teamwork

• Strong leadership technical writing and communication/presentation skills

• Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information

• Work schedule flexibility asto support 24/7 operations requiring occasional after-hours engineering coverage

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team!

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 and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

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 disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.