Forge Biologics · 7 hours ago
GMP Equipment Monitoring Technician, 3rd Shift
Forge Biologics is dedicated to enabling access to life-changing gene therapies. They are seeking a 3rd Shift GMP Equipment Monitoring Technician to oversee and consolidate manufacturing data, generate reports on equipment performance, and collaborate with cross-functional teams to improve equipment maintenance processes.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Continuously monitor GMP (Good Manufacturing Practice) and QC (Quality Control) equipment to ensure proper functionality
Perform regular maintenance and calibration of equipment to maintain accuracy and compliance with regulatory standards
Accurately record equipment performance data and maintenance activities in logbooks
Maintain detailed records and documentation for audit and compliance purposes
Diagnose and troubleshoot equipment issues promptly to minimize downtime
Conduct or coordinate necessary repairs and replacements of faulty components in collaboration with F&E through Blue Mountain Regulatory Assets Management software
Ensure all equipment monitoring and maintenance activities comply with GMP, QC, and regulatory requirements
Update regulatory changes and implement necessary adjustments to equipment monitoring protocols
Document calibration and validation processes and outcomes as per regulatory standards
Monitor environmental conditions (e.g., temperature, humidity) in manufacturing and QC areas
Assist QC teams with equipment setup and operation for testing and analysis
Ensure GMP/QC equipment is properly maintained and ready for use
Develop and execute preventive maintenance schedules for GMP and QC equipment
Proactively identify potential issues and address them before they impact operations
Maintain inventory of spare parts and consumables required for equipment maintenance and repairs
Ensure timely reordering of supplies to avoid interruptions in operations
Qualification
Required
Experience troubleshooting equipment within a manufacturing, laboratory, or other regulated environment
Ability to diagnose, troubleshoot, and resolve equipment issues in a timely manner
Excellent analytical and problem-solving skills to diagnose and resolve equipment performance issues efficiently
Strong documentation skills with attention to detail for maintaining logbooks, audit records, and compliance documentation
Ability to work independently and collaboratively across cross-functional teams, including Process Development, Quality, Facilities & Engineering
Strong organizational and time-management skills to prioritize tasks and meet operational deadlines
Ability to work in loud noise environments, and in cleanroom environments, while wearing appropriate gowning and Personal Protective Equipment (PPE)
Ability to work flexible 3rd shift hours, including weekends and holidays, in support of GMP production schedules
High School diploma required
Benefits
Health from day one
Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
A competitive paid time off plan – because rest fuels innovation.
12 weeks of fully paid parental leave so you can focus on family when it matters most.
Annual bonus opportunities for all full-time team members.
401(k) with company match to help you plan for the future.
Special employee discounts, including childcare and dependent care savings.
Onsite fitness facility at The Hearth.
Mental health counseling and financial planning services through our Employee Assistance Program.
Employer-paid short and long-term disability coverage to protect your peace of mind.
A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.
Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
Company
Forge Biologics
Forge Biologics is a gene therapy development engine, enabling access to life changing gene therapy programs.
H1B Sponsorship
Forge Biologics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (2)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
$330MKey Investors
State of OhioMidCap FinancialRA Capital Management
2023-11-13Acquired
2022-09-12Series C· $90M
2022-01-10Grant
Leadership Team
Recent News
2025-12-24
Company data provided by crunchbase