Maintenance Specialist
Company:
OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased-appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with full regulatory systems capabilities and resources to enable CMC data supporting regulatory applications. Manufacturing and development spaces are designed to be autonomous while interconnected to systems required to support clinical and commercial requirements.
We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.
Place of Performance:
CII George Sanders, Aguadilla Pueblo, Aguadilla, P.R. 00603.
The Maintenance Specialist is responsible for maintenance and calibration program development, execution, and oversight within a cGMP manufacturing environment. This role supports both start-up and commercial operations by ensuring equipment reliability, regulatory compliance, and lifecycle management of facility systems, utilities, and infrastructure.
Maintenance & Calibration Program Development (Start-Up Phase)
- Develop, implement, and oversee the site’s maintenance and calibration systems, procedures, and CMMS configuration in alignment with cGMP and regulatory expectations.
- Build asset hierarchies, equipment criticality assessments, job plans, calibration standards, and preventive/predictive maintenance strategies.
- Support commissioning, qualification, FAT/SAT, engineering design reviews, and change control to ensure maintainability, reliability, and lifecycle compliance.
- Author and maintain maintenance-related SOPs, work instructions, calibration methods, and controlled forms.
- Establish initial spare parts strategies, stocking levels, and vendor service frameworks.
Maintenance Leadership (Commercial Operations Phase)
- Coordinate and direct preventive, predictive, and corrective maintenance and calibration activities.
- Lead, supervise, and develop maintenance and calibration personnel.
- Ensure maintenance teams are trained for aseptic interventions, cleanroom entry, gowning, and safety protocols.
- Collaborate with Production, Engineering, Supply Chain, and QA to align schedules with production priorities.
- Oversee maintenance of HVAC, environmental controls, critical utilities, and cleanroom infrastructure.
Reliability, Investigations & Continuous Improvement
- Own site maintenance metrics (uptime, OEE, MTBF, MTTR) and prepare KPI reports.
- Lead troubleshooting, root-cause analysis, and deviation investigations.
- Implement reliability improvements and predictive maintenance technologies.
- Lead cost-saving, safety-enhancing, and efficiency-focused improvement initiatives.
GMP Compliance & Quality Support
- Ensure all maintenance and calibration work adheres to cGMP, safety, environmental, and labor regulations.
- Maintain ALCOA+ data integrity for all maintenance and calibration records.
- Support internal/external audits and serve as SME for maintenance.
- Maintain qualified state of validated systems and support validation activities.
Systems, Budget & Administrative Responsibilities
- Serve as CMMS system owner.
- Develop and manage the maintenance budget.
- Manage procurement, spare parts, and external service providers.
- Manage attendance in ADP and participate in daily/weekly meetings.
- Bachelor’s degree in Mechanical, Electrical, Chemical Engineering, or related field.
- Minimum five (5) years of maintenance management experience in pharmaceutical, biologics, or medical device manufacturing.
- Experience with aseptic operations, critical utilities, and GMP requirements.
- Proven leadership and organizational skills with ability to drive reliability and continuous improvement.
- Strong analytical, problem-solving, and technical writing skills.
- Experience with maintenance best practices, reliability engineering, and OpEx tools (preferred).
- Proficient in MS Word, Excel, PowerPoint, and Project.
- Excellent communication and presentation skills.
- Maintenance program development and CMMS management.
- Reliability engineering and KPI management (OEE, MTBF, MTTR).
- Equipment lifecycle management and calibration systems.
- Root cause analysis and troubleshooting.
- Preventive, predictive, and corrective maintenance strategies.
- Combination of office and manufacturing environment work.
- Ability to sit, stand, and walk for extended periods.
- Ability to lift up to 25 pounds occasionally.
- Required use of appropriate PPE in laboratories, cleanrooms, and utility areas.
- May require occasional after-hours or weekend support depending on operational needs.
- Competitive salary (DOE.)
- Health, dental, and vision benefits
- Professional training and development opportunities
- Opportunities to participate in the company stock options program
We Are an Equal Opportunity Employer
OcyonBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you are looking to contribute to a growing organization advancing next-generation therapies while building your career in a dynamic and collaborative environment, OcyonBio offers the opportunity to make a meaningful impact. Join us as we continue shaping the future of healthcare.
To learn more about us, please visit our website: https://ocyonbio.com
