Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order
Ensure necessary commissioning and qualification of systems is completed and interact with inspectors
Develop metrics-based performance focused on the maintenance systems effectiveness and operating level performance.
Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, identifying spare parts, job plan development and supporting engineering runs.
Ensure systems are installed and operating safety and align with pertinent environmental health/safety practice, rules and regulations
Responsible for determining appropriate CAPAs, action plan development, QMTS data entry, owns the record, initiate child CAPA’s and CAPA EVs, timely closure and responses, provision of technical data and reports.
Use tools and techniques of continuous improvement wherever possible. Establish equipment monitoring parameters and control limits. Routinely provide updates on metrics. Provide 2nd tier trouble shooting to support ops and maintenance groups as follow on from tier 1 initial problem solving. Change over reduction projects. Failure trending
Up to 10% domestic travel
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic Qualifications
Doctorate degree
OR
Master’s degree and 2 years of engineering experience
OR
Bachelor’s degree and 4 years of engineering experience
OR
Associate’s degree and 8 years of engineering experience
OR
High school diploma / GED and 10 years of engineering experience
Preferred Qualifications
Bachelor’s degree in Biotechnology, Industrial, Chemical or Mechanical Engineering
6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, chromatography, filtration, filling, lyophilization, inspection, device assembly, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
Strong leadership, technical writing, and communication/presentation skills
Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time
What you can expect from 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, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
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 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
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
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. 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.
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- Salary Range
- 115,494.60USD -156,257.40 USD
