Reliability Engineer, Biopharma & Predictive Maintenance

BioSpace

Boca Raton (FL)

On-site

USD 90,000 - 130,000

Full time

10 hours ago
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Benefits offered by this job

401K plan with employer match
Medical, Vision, Life and Dental
Pet Insurance
Paid Holidays
3 Weeks’ Paid Time Off

Job summary

ADMA Biologics is seeking a Reliability Engineer to provide maintenance reliability and predictive maintenance support for the manufacturing facility. You will develop and implement reliability tools, perform root-cause analyses, and ensure cGMP compliance across all equipment.

The role requires a minimum of 5 years in reliability/maintenance within a pharma/biotech setting, proficiency with data analysis and MS Office, and the ability to work in a fast-paced, regulated environment.

Qualifications

  • Bachelor’s degree in mechanical engineering or equivalent.
  • Minimum of 5 years of reliability engineering/maintenance in a cGMP, Pharmaceutical/Biological environment.
  • Experience with process equipment (pumps, centrifuges, refrigeration, fluid flow).
  • Ability to follow cGMP’s with great attention to detail and interpret regulations.

Responsibilities

  • Ensure reliability and maintainability of new and modified installations throughout the LCAM life cycle.
  • Develop acceptance tests and inspection criteria for equipment and vendors.
  • Support factory/site acceptance testing to meet functional specs.
  • Develop an Asset Maintenance Plan including preventive and predictive maintenance.
  • Analyze assets for utilization, OEE, remaining useful life, and costs.
  • Apply RCA, RCFA, FMEA, FRACAS and PHA methodologies.
  • Collaborate with operations to improve reliability and cost efficiency.

Skills

Blueprint reading
Regulatory compliance
Data analysis
FDA compliance
Problem solving
MS Office proficiency

Education

Bachelor's degree in mechanical engineering

Tools

Microsoft Project
Excel
Microsoft Word

Job description

ADMA Biologics is seeking a Reliability Engineer to provide maintenance reliability and predictive maintenance support for the manufacturing facility. You will develop and implement reliability tools, perform root-cause analyses, and ensure cGMP compliance across all equipment.

The role requires a minimum of 5 years in reliability/maintenance within a pharma/biotech setting, proficiency with data analysis and MS Office, and the ability to work in a fast-paced, regulated environment.

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