Job Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Responsibilities:
- Perform scheduled and unscheduled maintenance on GMP assets and ensure proper documentation of all work performed.
- Troubleshoot equipment and system failures, identify root causes, and implement corrective and preventive actions.
- Coordinate equipment relocation efforts to ensure assets remain undamaged and within specification after moves.
- Support new equipment installation, including Factory and Site Acceptance Testing (FAT/SAT), qualification protocol execution, and maintenance plan development.
- Manage equipment tools and spare parts inventory, ensuring tools are properly maintained, tracked, and readily available.
- Develop and maintain equipment task lists and maintenance plans based on manuals, manufacturer input, and historical data.
- Draft, review, and/or approve SOPs, specifications, change controls, work permits, and other controlled documents.
- Train personnel on equipment operation, maintenance procedures, cleaning, and safety protocols.
- Collaborate cross-functionally with QA, operations, planning, purchasing, and other departments to execute GMP asset tasks.
- Provide emergency on-call support as required, including participation in a 24-hour support rotation.
- Ensure compliance with all safety, sustainability, and regulatory standards. Promptly report and address safety issues.
- Support budgeting and expense tracking for maintenance and spare parts procurement.
Requirements:
- Minimum of 5 years' experience in a GMP-regulated environment performing equipment maintenance or technical support.
- Proven experience with equipment qualification, commissioning, and decommissioning.
- Strong troubleshooting and root cause analysis skills.
- Familiarity with maintenance management systems (CMMS) and documentation practices in GMP environments.
- Ability to read technical manuals, schematics, and equipment documentation.
- Strong written and verbal communication skills.
- Experience supervising contractors is a plus.
- Must be able to work independently and as part of a cross-functional team.
- Commitment to safety, quality, and continuous improvement.
- Technical certification or associate's degree in a mechanical, electrical, or engineering-related field.
- Experience in pharmaceutical, biotechnology, or other regulated industries.
- Knowledge of FDA, EMA, and/or ISO regulations as they pertain to GMP maintenance.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Job Tags
Contract work, For contractors, Immediate start, Relocation, Work visa,