Country United States
City Irvine, California
Functional Area Operations
Job Group Maintenance & Facilities
Employment Type Permanent Contract
Working time Full-time
At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.
Your role
Scope and Purpose of Position
The Maintenance & Facilities Engineering Manager is responsible for overseeing the maintenance, calibration
and reliability of pharmaceutical manufacturing facilities, ensuring compliance with industry standards,
regulations, and Good Manufacturing Practices (GMP). This role includes managing maintenance teams,
developing preventative maintenance programs, and ensuring the operational efficiency of critical equipment
and systems. The position is responsible to evaluate the equipment and systems for current capacity requirements,
equipment performance and make recommendations to meet these demands.Key Responsibilities:
Facility Maintenance and Equipment Reliability:
- Oversee the maintenance, calibration, repair, and optimization of pharmaceutical manufacturing equipment and facilities.
- Closely monitors, identifies and communicates problems in every phase of general maintenance and calibration of the business, including areas of electrical work, HVAC, plumbing, mechanical, equipment, painting and other minor repairs and cleanliness.
- Ensure the proper functioning of HVAC, cleanrooms, compressed air system, water purification systems, and other critical systems. ? Develop and implement preventative maintenance schedules to minimize downtime and maximize equipment lifespan.
- Ensures proper training and qualifications of department personnel are maintained.
- Ensures appropriate spare parts program for all critical equipment is maintained.
- Work closely with engineering, supporting new engineering projects and ongoing facilities improvements.
- Any and all other duties as assigned by immediate supervisor.
- Maintain compliance with GMP, FDA, ISO and other regulatory standards.
- Ensure all maintenance activities are thoroughly documented in line with industry and regulatory requirements.
- Support audits and inspections by regulatory bodies, providing required maintenance records and reports.
- Ensures proper training and qualifications of department personnel are maintained ? Responsible for Clean Room certifications.
3. Team Leadership and Development:
- Lead, mentor, and train the maintenance team to ensure high performance and skill development.
- Foster a culture of safety, efficiency, and continuous improvement within the maintenance department.
- Manage scheduling, workload distribution, and performance evaluations for the maintenance team.
- Responsible for 7-day/24 hour on-call responses as needed
- Develop contingency plans for critical equipment failures to minimize impact on production.
- Provide on-call support for urgent maintenance needs and ensure rapid response to unplanned downtime
Your profile
Required Knowledge, Skills and Abilities
- Ability to function well in a team environment.
- Strong oral and written communication skills.
- Must interface well cross-functionally.
- Good analytical skills and computer skills.
- Must be capable of using good reason and judgment to make and defend recommendations.
- Demonstrate hands on technical ability.
- Ability to work in a fast-paced environment with changing priorities.
- Must understand water sanitization and autoclave operation processes.
Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, or related field) or equivalent technical training.
Seven+ years of experience in maintenance management, preferably in the pharmaceutical or regulated manufacturing industry.
Strong understanding of GMP, FDA, ISO and regulatory compliance requirements.
Expertise in equipment maintenance, reliability engineering, and predictive maintenance tools.
Proficiency in Computerized Maintenance Management Systems (CMMS).
Excellent leadership, organizational, and communication skills.
Ability to manage budgets and negotiate vendor contracts.
Preferred Skills and Certifications
Certification in Reliability-Centered Maintenance (RCM) or Certified Maintenance and Reliability Professional (CMRP).
Experience with Lean Manufacturing or Six Sigma methodologies.
Knowledge of pharmaceutical production processes and cleanroom environments.
Target Salary Range: $110,000 - 120,000
Working at Siegfried
Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.
Who we are
In the Midst of People’s Lives – Across the Globe The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model. The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production. We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.
What we do in Irvine
Irvine is one of Siegfried’s sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices.
Main activities
- Provides cGMP sterile drug product fill finish of biologics, suspensions, emulsions, ointments, and gels
- All fully cGMP and SHE compliant
Features
- Commercial Products: 5 automated filling lines, Commercial manufacturing, Batch sizes up to 150 K units, Fill Volumes 0.5 ml – 100 ml
- Semi-automated and automated visual inspection
- Automated packaging with digital data visual verification
- Stability study services
- Drug delivery
- Laboratory services
- Clinical Products small lot capability (semi-automated filling, batch sizes up to 5 K units)
- Clinical manufacturing (batch sizes less than 5 K units)
Strategic importance
- CDMO for innovative and difficult-to-manufacture products from clinical to commercial NDA and ANDA products
- Provides contract sterile drug product manufacturing and laboratory services to the pharmaceutical and biotechnology industries