Sr. Associate Technical Engineer- Day Shift

In this vital role you will provide technical mechanical and electrical engineering support on all system/equipment optimization strategies, upgrades, replacements, repairs, and modifications. You will evaluate and determine if process equipment maintenance, and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area.

• Take part in the coordination of tech support on engineering, regulatory, compliance, quality, technical cleaning, validation, and mechanical/electrical equipment issues.
• Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
• Assist in planning, scheduling, and coordinating maintenance activities.
• Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and Amgen policies.
• Investigate complex issues or problems
• Assist with maintaining an up-to-date working spare parts inventory system for the equipment/systems.
• Create maintenance procedures and assist in changes to optimize the maintenance program, troubleshoot and repair equipment/system failures.
• Develop technical guides and trainings for repetitive tasks.
• Provide training to others for continuous team development.
• Be the point of contact for leading a team of technicians on mechanical and electrical breakdowns.
• Identify improvement opportunities and lead small projects.
• Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
• Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and P&IDs.

• Master’s degree
• Bachelor’s degree and 2 years of Technical Engineering experience
• Associate’s degree and 6 years of Technical Engineering experience
• High school diploma / GED and 8 years of Technical Engineering experience

• Educational background in Mechanical Engineering, Mechatronics, or related technical degree
• Experience repairing mechanical equipment in a manufacturing environment (experience with packaging equipment preferred)
• Experience working in a regulated industry (ideally GMP, Pharmaceutical)
• Knowledge of Reliability Maintenance and Process Optimization
• Knowledge in continuous improvement tools and methodologies
• Familiarized with Computer Maintenance Management Software (preferably Maximo
  7)
• Strong mechanical aptitude and troubleshooting skills
• Understanding in PLC, Computer Serialization, Packaging Equipment, Vision Inspection System (Cognex Vision System and Systech Serialization)
• Excellent organizational, project management, problem solving and technical writing capability
• Strong communication skills: verbal / written, collaboration, influencing and facilitation
• MS Office:
  Word, Excel, Power Point

• 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.

Sponsorship:
Sponsorship for this role is not guaranteed.

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.