Roche - Genentech, a global leader in bio-pharmaceutical industry, committed to the discovery, development, and delivery of innovative medications, is driven to achieving the GMP operational excellence. We hire the best, the most talented, and motivated people. Through a culture of inclusion, respect, and openness we create a better, more productive work environment. We believe in cross-functional experiences and perspectives for all our employees as it helps to enhance the creativity and foster innovation translating into transformative business results.
This position is for an Asset Management (AM) Utility Engineer and Discrepancy Owner (DO) role within the Facilities and Engineering (F&E) Department in South San Francisco Production (SSFP). This position reports to the Utilities Engineering and DO Manager in the SSFP Facilities & Engineering Department.
Act as system owner for all water, steam, glycol, gas, and bulk distribution Utility systems within SSFP and discrepancy owner for Facilities and Engineering SSFP.
Act as the Discrepancy Owner for Utilities equipment and processes within Facilities and Engineering.
Support the timely closure of discrepancies. Escalate process issues as necessary.
Monitor discrepant events and evaluate trends, report repetitive anomalies, observations, and gaps to management.
Support corporate goals and department objectives including on time discrepancy closure, reduction of recurring/repeating discrepant events, and overall reduction of discrepancy volume.
Ensure that system related documentation and master data is accurate and current.
Review operation and maintenance Standard Operating Procedures (SOPs) to ensure accuracy and that they deliver compliant and reliable performance.
Monitor system condition, performance, reliability and escalate issues for resolution as needed.
Provide oversight of technical changes on systems.
Provide discrepancy and investigation support, including corrective measures.
Escalate quality, safety, and business risks as appropriate.
Support planning efforts for annual shutdowns, including coordination of all activities to ensure full completion of tasks.
Support internal and external regulatory compliance audits.
Support customer needs by maintaining clear communications with all internal departments and with external contractors, vendors, and service providers.
Develop and implement training for all Utilities personnel associated with new and existing Utility and associated subsystem equipment.
Determine component/equipment repair, replacement, and retirement strategies
Support project engineering, manufacturing operations, utilities, and facility maintenance as subject matter expert.
Perform technical reviews for spare parts requirements and obsolete component replacements.
Bachelors of Science degree or equivalent with 5 - 10+ years of experience in Biopharmaceutical production.
Thorough knowledge of cGMP regulations and familiarity with FDA regulatory process.
Thorough knowledge of pharmaceutical manufacturing facility operation and maintenance.
Ability to read and understand P&IDs, engineering drawings and specifications, SOPs, and have advanced computer skills using word processors, spreadsheets, databases, and email.
Practical knowledge of equipment maintenance, operation, control and cleaning for: process equipment; process air systems; clean utility systems; waste neutralization systems; and bulk chemical and gas systems.
Ability to manage complex projects and provide direction to engineering consultants and contractors.
Detail oriented and demonstrate good record keeping practices.
Must be able to demonstrate effective communication and interpersonal skills with technical and non-technical personnel, including Manufacturing, Quality, and Senior Management.
Advanced engineering degree and/or certification in maintenance and reliability, experience with SAP Plant Maintenance module, and cGMP knowledge is desirable.
WORK ENVIRONMENT/PHYSICAL DEMANDS/SAFETY CONSIDERATIONS
Work in standard office environment and/or GMP controlled environment.
Schedule could include a non-rotating 4-day (10 hour shift), one weekend day, evening or night hours, or full off-shift hours.
Expected to be on feet for 8 to 10 hours a day.
Climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.
Lifting up to 25lbs may be required.
Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn.
No makeup or jewelry can be worn when working in the clean room environment.
Work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.
Work with hazardous materials and chemicals.
Roche is an equal opportunity employer.
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Sep 24th 2021