Sr. Equipment Engineer

2 Days Old

Sr. Equipment Engineer $120k-$140k DOE
Position Overview
The Senior Equipment Engineer is responsible for maintaining and improving the reliability of manufacturing equipment in a regulated biopharmaceutical production environment. This role requires deep technical expertise in automated systems, regulatory knowledge, and the ability to troubleshoot equipment issues quickly to minimize downtime.
Compensation & Benefits
Annual Salary Range: $120,000 – $140,000 (based on experience, skills, education, and location)
Benefits include:
Medical, Dental, and Vision Insurance
Company-Paid Life Insurance (1x Annual Salary)
Voluntary Life Insurance Options
Short-Term and Long-Term Disability Insurance
Flexible Spending Account (FSA) & Health Savings Account (HSA)
401(k) Retirement Plan with Company Matching
14 Days Paid Time Off (PTO)
10 Paid Holidays Annually
Key Responsibilities
Provide technical support for cGMP manufacturing equipment (e.g., automated filling lines, isolators, environmental monitoring systems, building management systems).
Troubleshoot automation system issues and implement corrective actions to minimize downtime.
Program and configure Allen-Bradley and Siemens PLCs, SCADA systems, and HMI interfaces.
Oversee and collaborate with service technicians for maintenance, upgrades, calibrations, qualifications, and repairs.
Lead preventive and predictive maintenance programs.
Author and maintain documentation such as functional specifications, SOPs, calibration and validation records, change controls, investigations, CAPAs, and other cGMP records.
Partner with Operations and Quality to execute continuous improvement projects.
Serve as Subject Matter Expert (SME) during audits and inspections, offering technical expertise and documentation support.
Manage competing priorities while maintaining tight project timelines.
Willing to work irregular hours as needed, including weekends or nights.
Perform other duties as assigned.
Qualifications
5+ years of experience with automated biopharmaceutical manufacturing equipment in a regulated environment
Bachelor’s or Master’s degree in Engineering preferred
Knowledge of sterile manufacturing and aseptic techniques
Familiarity with global regulatory standards (e.g., ISO 13485; 21 CFR 210, 211, 820, Part 11; EU Annex 1)
Strong experience with technical documentation, SOPs, and validation protocols
Proven track record leading equipment-related investigations for nonconformances and deviations
Highly organized, detail-oriented, and analytical
Proficient with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
Strong written and verbal communication skills
Location:
Us