Remote Manufacturing Systems Engineer – MES & Automation

BioSpace

Holly Springs (NC)

On-site

USD 143,000 - 165,000

Full time

3 days ago
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Benefits offered by this job

Stock options
Retirement plan
Medical insurance
Life insurance
Disability insurance
Bonus eligibility

Job summary

Amgen is seeking a Senior Manufacturing Systems Engineer to own the design and technology of the Manufacturing Information & Technology ecosystem, while collaborating with business partners to advance the lifecycle and automation of manufacturing applications.

You will lead PoC automation projects, enable data integrations using SQL/Web Services, and ensure compliance with GxP and 21 CFR Part 11 in a regulated environment. Strong Agile and analytics skills are required.

Qualifications

  • Bachelor's degree in Mechanical Engineering, Engineering or related field with 4 years of experience.
  • Experience with MES enhancements and application upgrades.
  • Knowledge of SQL, Web Services, and data integrations.
  • Familiarity with 21 CFR Part 11 in regulated environments.
  • Experience with automated solutions across SaaS/Cloud/On-prem platforms.
  • Agile methods for developing training materials and processes.
  • Ability to translate requirements into functional specifications.

Responsibilities

  • Own and shape the design and technology of the Manufacturing Information & Technology ecosystem.
  • Develop a vision and multi-year roadmap for applications lifecycle management.
  • Manage portfolio of IS projects with planning, risk, and financial oversight.
  • Collaborate with delivery and platform teams to align applications with guidelines.
  • Lead efforts to design and develop rapid PoC automated solutions and services.
  • Work with partners to identify automation opportunities to improve workflows.
  • Synthesize requirements from users, architects, and cybersecurity teams to optimize automation.

Skills

MES PASX
SQL
Web Services
GxP Part 11
Change control
Validation
Automation
Cloud/On-prem
Agile
Business analysis
Databases & reporting

Education

Bachelor's in Mechanical Engineering or related field

Job description

Amgen is seeking a Senior Manufacturing Systems Engineer to own the design and technology of the Manufacturing Information & Technology ecosystem, while collaborating with business partners to advance the lifecycle and automation of manufacturing applications.

You will lead PoC automation projects, enable data integrations using SQL/Web Services, and ensure compliance with GxP and 21 CFR Part 11 in a regulated environment. Strong Agile and analytics skills are required.

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