Country United States
City Irvine, California
Functional Area Operations
Job Group Support Functions
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
Sr. Safety, Health, and Environment Specialist / SHE Officer will have direct responsibility for the design, implementation, adoption, and management of a company-wide safety and health program that integrates the use of a best-practice of the Siegfried EHS system in adherence with local state and federal regulations. The incumbent will work independently to review and interpret regulatory requirements in addition to day-to-day management and oversight of (but not limited) the following areas:
• Occupational Safety and Health
• Environmental Protection
• Hazardous Waste Management
• Air Pollution Prevention
• Medical Waste Management
• Water Pollution Prevention
• Electronic and Universal Waste
• Fire Protection and Building codes
Responsibilities
• Assures compliance with Federal, State, and local safety, health, and environmental regulations to include applicable Cal-OSHA and OSHA safety initiatives for our field operations.
• Interface with all government agencies and submit the proper regulatory permit application to the Fire Department, Air Pollution Control District, Department of Environmental Health, Metropolitan Waste Water Authority, Stormwater Control Authority, California Environmental Protection Agency, and California Occupational Health & Safety Administration.
• Develops safety, health, and environmental protection training programs and materials required to qualify loss control/environmental protection personnel in technical competence, plan implementation, prepare training, and develop motivational techniques.
• Coordinates the development of safety, health, accident loss control, and environmental protection strategic plans to cover short-range operating periods of 1-2 years and goals for continuous improvement over long-range periods of 3+ years.
• Oversees the collection, storage, and removal of the Irvine site's hazardous, Biological, Chemical, Electronic, and universal wastes.
• Assesses and minimizes the risk of injury to people and liabilities arising from accidents. Environmental exposures in or associated with the workplace, performing accident investigation and ergonomic assessments.
• Evaluates, recommends, and implements a comprehensive EHS management software for our industry and is based upon experience with such systems
• Manages the ISNetworld database and provides required health, safety, quality, risk, and regulatory information, as needed, to meet or exceed client requirements
• Provides professional technical assistance and motivation in formulating, continuing, and adopting safety, health, environmental protection, property conservation, security, and motor vehicle safety programs.
• Develops and maintain benchmarking standards (KPI) that will permit meaningful measurement of our effort to meet safety, health, and environmental objectives
• Analyzes and evaluates the capabilities of the individual and the organization's safety, health, and environmental protection operations at any stage in developing procedures.
• Oversees the Hazard Communication program ensuring proper labeling across the site.
• Lead and train the Emergency Response team that is on call 24/7. Maintain the HAZWOPER/HAZMAT certification.
• Establish and maintain business continuity and contingency plans to ensure the site's security.
• Coordinates safety audits/inspections with agencies and authorities as needed.
• Conduct periodic EH&S audits, evaluate process improvements, and support the product safety evaluations for the site
• Oversees the restricted Substance Management program and Safety Data Sheets (SDS) management for the site.
Your profile
Required Knowledge, Skills, and Abilities
• Ability to function well in a team environment.
• Strong critical thinking and organizational skills
• Strong oral and written communication skills.
• Detail-oriented with the ability to multi-task in a fast-paced environment
• Ability to manage multiple projects, deadlines, and priorities
• Must interface well cross-functionally.
• Good analytical skills and computer skills.
• Must use sound reason and judgment to make and defend recommendations.
• Ability to work in a fast pace environment with changing priorities
• Knowledge of OSHA, EPA, and DOT regulations
Desired
• Certified Safety and Health Manager (CSHM), Certified Industrial Hygienist (CIH) and Certified Safety Professional (CSP)
• Proven ability to drive change in a fast-paced, entrepreneurial organization
• Experience with construction-related, professional services, and environmental work.
• Experience implementing company-wide EHS software and tracking systems, experience with remote applications/mobile-friendly safety software, and experience with lone worker safety management.
• Knowledge of operational excellence methodologies and tools (e.g., Six Sigma)
Required Education and Experience
• Bachelor degree
• 3-4 years of relevant industry experience or an appropriate combination of education and experience.
• Three years in a pharmaceutical manufacturing environment. The medical device environment will be considered.
• Experience implementing and using an EHS system and procedures.
• Hazmat Emergency Responder Certification highly desired
Target Salary Range: $85,000 - 105,000
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