Senior Manager Manufacturing Systems Engineering Automation

Amgen

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profile Job Location:

Holly Springs, MS - USA

profile Monthly Salary: $ 220919 - 220919
Posted on: 9 hours ago
Vacancies: 1 Vacancy

Job Summary

Career Category

Engineering

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel likeyourepart of something biggeritsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980wevehelped 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 teamyoullhelp 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 thatliewithin themyoullthrive 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 AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch 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 Systems Engineering - Automation

What You Will Do

Letsdo this.Letschange the this role The Senior Manageris responsible forproviding technical and administrative leadership to a group of Automation Engineers accountable for administrating andmaintainingautomation systems for Drug Substance manufacturing at AmgenNorth Carolina(ANC). Responsibilities include meeting key performance metrics leading and technically developing reports and ensuring all targets and turning points are completed on time. The Sr. Manager also ensures that the automation teamappliesthe Corporate Automation Business Processes and drivers to deliver the automation services to theorganization.

As part of the Facilities& Engineering (F&E) group the Senior Manager will work with the Director of Engineering atAmgenNorth Carolina. This role is expected to provide leadership as follows:

  • Lead a team of Automation Engineers and serve as the main point of contact for automation function forANC1manufacturing.Systems including Allen Bradley PLCs SiemensDesigoCCforbuildingautomation and EmersonDeltaVfor process control.

  • Define drive and deliver the automation and process control strategy within Drug substance manufacturing.

  • Serve as an experienced advisor to senior level management and ensure the automation development strategy aligns with Amgen Process Development strategy.

  • Strategic and tactical management and leadership in providing 24x7 day-to-day operational support mentoring staff development team productivity and efficient use of available resources.

  • Develop support structures with internal/multi-functional teams for capital projects plant support and Amgen network-level initiatives execution.

  • Providinput into departmentobjectivesandestablishingstrategic direction within the Drug Substance Network for the F&E automation team.

  • Maintain and improve capabilities and automation systems reliability in partnership with F&E and plant leadership and other technical staff in the network focusing on Maintenance Excellence systems failures and recurrence avoidance.

  • Work with diverse groups (Manufacturing Quality PD AutomationTechnology EHSS Global Engineering) and drive new business processes to ensure continuous and sustained improvements. Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical/business proposals.

  • Identifyareas of potential improvement conduct analysis recommend solutions sponsor improvement projects and implement.

  • Ensure site readiness and compliance for internal audits external agency audits and partner audits.

  • Ensure the safety of all personnel during plant operations and engineering activities.

  • Develop expense budgetforecastand adhere to department budgets and spendforoperational and capital expenses holding 100% accountability.

  • Be knowledgeable about compliance and regulatory aspects for operation and maintenance equipment validation and support regulatory inspections and audits.

  • Ensure Amgen Enterprise cyber resiliency compliance ismaintainedat 100%.

  • Ensure the right processes/systems are in place to capture 100% quality compliance for the right-first-time(RFT) delivery of automation solutions.

  • Ensure that reporting functionality is incorporated for all unit operations forproductionBatch records cleaning and sterilization systems including Audit trail and version control.

  • Responsible for ensuring that service contracts with all OEMs for systems areestablishedfor service and support needs including service banked hours for specialized support needs.

  • Ensure that all automation staff are adequately trained and follow all GMP standards and procedures by managing the teams internal and external training needs.

  • Ensure the automation staff are fully aware and confident to work on all automation systems process equipment andfacilityto provide 24x7 reliable plant automation support.

  • Responsible for ensuring that the automation team activelyparticipatesin daily/weeklyWork Center Team (WCT)meetings Manufacturing area& plant WCTs Automation WCT Automation leadership WCT etc. to address day-to-day topics and discuss issues with multi-functional teams to resolve.

  • Responsible for ensuring the automation team provides the required support to implement expense department capital construction and GLAM-DTI projects.

  • Provide active leadership such that proactive feedback issolicitedfrom the automation staff and actions are taken tomaintainproper work-life balance.

What We ExpectOfYou

We are all different yet we all use our unique contributions to serve patients. The engineering management professional weseekwillpossessthese qualifications.

Basic Qualifications:

  • High school diploma / GED and 12 years of Engineering and/or ProjectManagement experience OR

  • Associates degree and 10 years of Engineering and/or Project Management experience OR

  • Bachelors degree and 8 years of Engineering and/or Project Management experience OR

  • Masters degree and 6 years of Engineering and/or Project Management experience OR

  • Doctorate degree and 2 years of Engineering and/or Project Management experience

  • Additionally: In addition to meeting at least one of the above requirements you must have a minimum of 2years experiencedirectly managing people and/or leadership experience leading teams projects programs or directing the allocationorresources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

  • Degree in Electrical Engineering Computer Science Chemical Engineering Biotech Engineering or related field

  • Experience with EmersonDeltaVDCS system SiemensDesigoCC Allen BradleyPLCand ability to perform advanced troubleshooting and system integration using OPC Foundation Fieldbus and Profibus technologies

  • Direct knowledge of automation system design

  • Experience in programming installation and lifecycle management of automation and field instrumentation technologies

  • Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold chromatographysingle usemixing vessels depth filtration and solution prep

  • Experience in integrating various OEM automation software

  • Experience in programming design installation and lifecycle management of manufacturing process controls and automation and field instrumentation technologies.

  • Fieldbus and Profibus technologies

  • Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11 ASTM 2500 S88 and S95

  • Self-directed team player able to work cross-functionally

  • Strong leadership technical writing and communication skills

Thrive

What you can expect of us

As we work to develop treatments that take care of others we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities including:

  • Comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts.

  • A discretionary annual bonus program or for field sales representatives a sales-based incentive plan

  • Stock-based long-term incentives

  • Award-winning time-off plans and bi-annual company-wide shutdowns

  • Flexible work models including remote work arrangements where possible

Apply nowfor a career that defies imagination

Objects in your future are closer than they appear. Join us.

#AmgenNorthCarolina

Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation toparticipatein 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.

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Salary Range

163288.40USD -220919.60USD

Required Experience:

Senior Manager

Career CategoryEngineeringJob DescriptionJoin Amgens Mission of Serving PatientsAt Amgen if you feel likeyourepart of something biggeritsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980wevehelped pioneer the world of biotech in our fi...
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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

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