Country United States
City Irvine, California
Functional Area Operations
Job Group Engineering
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
The Senior Facility Engineer at Siegfried in Irvine, CA is responsible for overseeing the design, construction, and maintenance of buildings within our sterile pharmaceutical manufacturing facility. This role focuses on working closely with the maintenance team and ensuring the efficient operation of critical utilities, clean rooms, GMP areas and other facilities. The Senior Facility Engineer will work closely with the Engineering Manager to develop plans for renovations and oversee these projects from initiation to completion.
Responsibilities
- Develop long-term plans to improve maintenance strategies on critical utilities and other infrastructural equipment
- Oversee the design and upgrades for classified clean rooms and other facilities.
- Responsible for managing key vendors for maintenance and compliance of the facility including but not limited to Hazardous Waste, HVAC, Electrical, Plumbing and Facility Modifications
- Supervise the design and development of critical utilities and ensure their efficient operation.
- Work with facilities and maintenance personnel, addressing problems in various maintenance phases.
- Develop and implement preventative maintenance programs for infrastructural equipment in compliance with company procedures.
- Performs engineering investigations related to equipment, utility, and facility
- Establish yearly budgets and mid-range capital equipment expenditure plans.
- Evaluate equipment and systems for current and future capacity requirements, making recommendations accordingly.
- Ensure compliance with cGMP and ISO requirements
- Audit maintenance and calibration work to ensure FDA, ISO, and procedural compliance.
- Oversee Facility Maintenance Work Order System and Maintenance Software System.
- Maintain an efficient spare parts program for critical equipment.
- Ensure cleanliness and organization of calibration/maintenance areas.
- Provide support for unscheduled maintenance repairs and collaborate on new engineering projects.
- Write Change Notices and deliver presentations on project status.
- Ensure facility repairs and improvements comply with city, state, and federal codes.
- Manage permits, licensing, sanitary discharge, backflow maintenance, and Hazardous waste programs.
- Interact with other Engineering teams for equipment identification and procurement.
- Act as a liaison with the building landlord, seeking approval for facility modifications.
- Oversee Clean Room certifications and guide the Building Emergency Plan.
- Other tasks assigned by the engineering manager
Your profile
Required Knowledge, Skills and Abilities
- Understanding of HVAC, Wastewater System, Electrical, Compressed Dry Air, Nitrogen, Vacuum & WFI Water Systems
- Hands-on experience with ISO clean rooms
- Understanding of ISO cleanroom standards and FDA requirements
- General GMP knowledge of pharmaceutical manufacturing facilities
- Ability to function well in a team environment
- Strong oral and written communication skills
- Excellent technical writing skills
- Must interface well cross-functional teams
- Good analytical and problem-solving skills
- CAPEX Management experience
- 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
Required Education and Experience
- Engineering Degree, preferred Mechanical or Chemical Engineering
- 10+ years of relevant Pharmaceutical/medical device experience
- 5 years of experience in project management
- 3-5 years of experience managing vendors and contractors
- PMP, Lean Six Sigma Green Belt, PE certification would be a plus
- AutoCAD proficiency
- Microsoft Project Proficiency
Target Salary: $135,000 - 150,000
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