Mfg Technologies Sr Mgr Holly Springs, NC
Holly Springs, MS - USA
Job Summary
What you will do
Lets do this. Lets change the this vital role you will manage a defined set of Manufacturing Execution Systems (MES) objects such as GMBRs (electronic batch records) and equipment management objects (ESPs state diagrams) that are utilized across all applicable manufacturing sites.
Specific responsibilities include but are not limited to:
Collaborate communicate be accountable for leading forums with multi-functional areas and make the appropriate decisions for the best interest of Amgen.
May include ownership of global MES SOPs in addition of provide input and review of related global training materials.
Strategize with Technology team on application roadmap and accommodating new offered functionality.
Own system related controlled documents such as data integrity assessment report operational SOPs and training content.
Lead and approve validation documents and records such as validation plan OQ protocol configuration specifications requirements specs validation summary (backup) report test scripts test sets and test runs mostly for MES but also some for ERP.
Additional Qualifications/Responsibilities
Basic Qualifications:
Doctorate degree and 2 years of Manufacturing support experience
OR
Masters degree and 4 years of Manufacturing support experience
OR
Bachelors degree and 6 years of Manufacturing support experience
Or
Associates degree and 10 years of Manufacturing support experience
Or
High School diploma / GED and 12 years of Manufacturing support experience
Beyond that additional preferred qualifications are:
Academic background in Life Science and/or Engineering.
Leadership experience managing contractors and indirect reports.
Background in Drug Substance Finish Drug Product (FDP) and/or Drug Product.
MES technology knowledge with experience modifying batch records.
Proficient communication skills in English.
Experience with MBR design in Koerbers PASX.
MES system experience in biological manufacturing floor operations.
Regulated environment work experience with cross-functional collaboration working in teams.
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 a Total Rewards Plan based on eligibility comprising of 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 that may include:
A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental & vision coverage life and disability insurance
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
Flexible work models including remote and hybrid work arrangements where possible
Salary Range
137416.10USD -185915.90 USD
Required Experience:
Manager
About Company
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