Note: Job description is not intended to be all-inclusive.
The responsibilities for this position may include, but are not limited to:
Responsible for performing maintenance for a variety of equipment and systems in a cGMP small molecule pharmaceutical production area.
Timely completion of tasks and work orders with appropriate documentation according to standard operating procedures, applicable standards, guidelines, practices, and policies.
Maintain LOTO equipment area and Confined Space Entry/Elevated Work equipment in accordance with Site EHS requirements
Interact and communicate appropriately with Manufacturing, Quality, FSPE, and other Site Operations support groups to ensure satisfactory performance of mechanical systems and process equipment.
Acting as the Facilities Operations and Maintenance (FOM) representative to the internal customer group.
Support and drive continuous improvement initiatives.
Perform maintenance and repair functions for new and existing equipment.
Ensure systems (including equipment, facilities and utilities) are maintained in accordance with cGMP requirements, Genentech maintenance specifications, and other applicable industry guidelines.
Responsible for ensuring that all relevant Standard Operating Procedures (SOPs) and operating parameters are followed and maintenance activities are properly documented utilizing Good Documentation Practices (GDP).
Make recommendations to help simplify and facilitate ongoing maintenance and repair.
Interact with key customers and stakeholders.
Perform PMs on production equipment and utilities, implementing and modifying SOPs, and working with Validation as required.
Support the completion of GMP documentation for DMS, TAC and CAPA related items.
Conduct investigations and recommend Corrective & Preventive Actions (CAPAs) for any utility or equipment discrepancy.
Conducting maintenance work in an FDA-regulated environment and supporting internal and external inspections.
Ensuring all corrective and preventative maintenance and mechanical tasks are performed at the appropriate interval and are completed by the assigned due date, including those activities performed by third party vendors.
Ensuring all equipment remains in its designed and/or validated state at all times.
Ensuring all equipment operation is in accordance with Federal, State, Local, and Genentech regulations, procedures, and policies.
Ensuring all equipment areas are maintained in a constant state of inspection readiness.
Assisting with the management and resolution of all technical equipment and facilities-related issues arising in the Small Molecule Pharmaceutical Science laboratories and associated utilities and production equipment.
Responding to customer requests for maintenance of manufacturing, packaging equipment, and utilities.
Troubleshooting problems and implementing solutions or improvements necessary to restore operations.
Responding to emergency calls in an expeditious manner (e.g., customer contact within 30 minutes of a call, in front of the equipment within 60 minutes).
Installing, maintaining, repairing and rebuilding encapsulation machines, tablet presses, isolators and milling equipment, temperature control units (TCUs) for bioreactors and packaging equipment for proper operation and personnel safety
Ensuring that the appearance and neatness of equipment within the area of responsibility meets the requirements of cGMP, SOP and other company policies.
Identifying critical spare parts and lubricants needed and ensuring that acceptable levels of those inventories are maintained in order to minimize equipment down time and maximize production efficiencies.
Troubleshooting refrigeration and HVAC systems to the component level and repairing said systems.
Follow all operational Standard Operating Procedures and Preventive Maintenance procedures for accuracy and applicability on a continuous basis. As required drive revision changes and corrections.
Assisting in the intradepartmental planning and development of preventive maintenance (PM) routines and associated schedules to ensure peak productivity and the highest quality possible.
Ensuring that all paperwork accurately reflects all work performed and/or observations made and is completed in a timely manner in accordance with SOPs and Good Documentation Practices (GDP).
Submitting appropriate change requests through the Facility Services Document Tracking Database to correct any deficiencies discovered.
Gathering and documenting the appropriate information associated with a System Discrepancy (an event in manufacturing process and/or support system that is outside approved operating parameters or approved procedures).
Ensuring training requirements are met at all times.
Identifying training deficiencies, providing recommendations for training and, where applicable, providing training.
Communicating effectively with manufacturing, research and development, and administrative customers.
Serve as the FOM organizational representative on technical and complex matters relating to equipment maintenance and operation.
Participating in cross functional teams that require identifying assignable root causes for any product or equipment related deviations or anomalies, and then establish and implement the necessary corrective and preventive actions needed to ensure the incident or anomaly is prevented in the future.
Performing all activities in compliance with company cGMP and safety policies, procedures and practices.
Walking or moving from one service call to the next, including preventative maintenance work, the majority of the day.
Working in loud environments that require ear protection and lifting 30-40 pounds regularly.
Working with various chemicals, steam, and pressurized gases and liquids of various temperatures.
Working with energized systems and working in close proximity to moving equipment.
The job may require entry into confined spaces and use of a respirator.
Using computers on a regular basis is required.
High School diploma or equivalent.
Requires a high level of mechanical, electrical and control systems knowledge, skills and experience in order to thoroughly assess any problems with the equipment, identify the problems, make the necessary repairs and then complete all associated cGMP documentation needed to appropriately document the work performed (e.g. work orders, change controls, etc.).
Experience with potent compounds strongly preferred.
A current universal refrigeration license in good standing preferred.
Preferred 10+ years Pharmaceutical industry experience with a thorough working knowledge of cGMP maintenance production in accordance with FDA regulatory guidelines. Other working experience in a regulated industry such as Aviation or Petrochemical will also be taken into consideration.
Direct cGMP maintenance experience with process equipment, plant utilities, as well as clean validated utilities: i.e. HVAC, Clean Dry Air, and Purified Water.
Technical degree or certificate a plus.
Desired completion of technical school or accredited two-year program.
May be required to work overtime and off-shifts, including weekends and holidays.
Must be able to provide off-hours emergency maintenance coverage.
Strong organizational planning skills required.
Excellent interpersonal effectiveness, communication, and customer service skills (written and oral) required, interfacing across departments and management levels.
Preferred familiarity of pharmaceutical solid dose production and packaging equipment.