Senior Manager Manufacturing Systems Engineering
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Job Location:
Holly Springs, MS - USA
Monthly Salary:
$ 201202 - 201202
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
Career Category
EngineeringJob Description
Join Amgens Mission of Serving Patients
At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.
Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.
Senior Manager Manufacturing System Engineering
What you will do
Letsdo this!Letschange the world! In this vital role you will oversee theAutomationEngineering team lead technical projects and drive innovation andsupportmanufacturingsautomation needs. You will solve complex engineering problemsand ensure the companys engineering efforts align with strategicobjectives. You will also provide leadership and guidance to theAutomation Engineering team supporting 24/7 manufacturing and facility operations.
TheSeniorManagerManufacturing System Engineeringwill join the Facilities & Engineering (F&E) groupreporting to theFacilities & Engineering (F&E)Director. This role will partnerclosely with the corporate engineering teamduring thedesign build commissioning and qualification phases.This role will be instrumental in developing automation domainexpertiseand supporting operational readinessandwill develop domainexpertiseto support operations upon start-up focusing onmanufacturing automationas well as hiring and training the staff required to support startup and operations.
Sitedesignconstruction start-up and operational readiness:
Build and lead a team ofAutomation engineeringprofessionals and serve as the main point of contact forthe Automation engineering function.
Support design reviews whilepartnering closely with the corporate engineering team.
Execute andsupport thecommissioning and qualification ofprocess equipmentautomationin 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.
Collaboratewiththe siteprocessengineering teamto understand key process requirements anddevelop process control automation solutionsprimarilyutilizingEmersonDeltaVDistributed Control System (DCS).
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).
Partner with various organizational units to support tasks including operational readiness document reviews deviationinvestigationand change controls.
Provide mentoring todevelopand acceleratesitetechnicalautomationcapabilities.
SiteOperations:
Lead a team of Automation engineer professionals and serve as the main point of contact for Automation engineering function.
Accountable for Automation System Administration Automation System Operating Systems (OS) andHotFixassessments and rollout preventative and correctivemaintenance AutomationSystem spare parts management and ownership of departmental Standard Operating Procedures (SOPs).
Manageday-to-dayautomationsupport including 24 x 7onsite/on-callsupport troubleshootinganddailymanufacturing and engineeringmeetings.
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)
Performautomationchangeassessments implement automation system configuration changesand supportengineering and process qualification runs.
Represent automation in cross-functional design reviews and audits.
Look for new and innovative ways to do business differentlybetterand more cost effectively.
Lead continuous improvement initiatives including improvements to safety reliability efficiency and sustainability.
Perform andmaintaindataintegrityin accordancewiththe current Amgen andindustry standards.
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 forAutomation engineering including forecasting costs managing expenditures and ensuring efficient allocation of resources.
Up to10% domestic/international travel
What we expect of you
We are all different yet we all use our unique contributions to serve patients. Theautomationprofessional weseekenjoys challenges and is motivated to help serve patients with these qualifications.
Basic Qualifications:
High school diploma / GED and 12 years of engineering experience OR
Associates degree and 10 years of engineering experience OR
Bachelors degree and 8 years of engineering experience OR
Masters degree and 6 years of engineering experience OR
Doctorate degree and 2 years of engineering experience
And
In addition to meeting at least one of the above requirements you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
Degree in Electrical EngineeringComputer Science Chemical Engineering or Biotech Engineering.
Extensive experience with EmersonDeltaV Process Control Network design including network segregation Process Control Systems: Virtual Infrastructure design and implementation System Integration using OPC Foundation Fieldbus and Profibus.
Handson experience with IO-Link technology for smart sensor/actuator integration in automated manufacturing environments.
Familiarity with Process Analytical Technology (PAT) tools and strategies for real-time processmonitoringand control in biopharmaceutical manufacturing.
Direct knowledge of integrating various OEM automation software and field instrumentation technologies.
In-depth knowledge ofindustry standardssuch as 21 CFR Part 11 ASTM 2500 S88S95GAMPGDPand GMP.
Experience working in a regulated environment (e.g.cGMP OSHA EPA etc.) experience interacting with regulatory agencies and inspectors and familiarity with GMP quality systems/processes such as change control non-conformances corrective and preventative actions and qualifications/validation
Experience with Tech Transfer Process Design and Commissioning & Qualification.
Direct knowledge of biopharmaceutical production facility with direct experience with Upstream (Seed train production Bioreactors Harvest) and Downstream Purification (e.g.Chromatography and viral Filtration skids UFDF) and CIP/SIP Skids.
Ability and willingness tomentor and develop engineeringstaff andembrace a team-based culture that relies on collaboration for effective decision-making.
Strong leadership technical writing and communication/presentation skills.
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.
Salary Range
148715.15USD -201202.85USDRequired Experience:
Senior Manager
About Company
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 ... View more
