Country United States
City Pennsville, New Jersey
Functional Area Operations
Job Group Production
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
SUMMARY:
The incumbent is responsible for operation of chemical manufacturing equipment and processes on a shift team to produce pharmaceutical bulk active ingredients and intermediates.
ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
• Demonstrates full competency in the operation of all chemical production equipment, such as reactors, kettles, stills, filters, centrifuges, pumps, and demonstrates advanced understanding of chemical processes.
• Must be able to obtain and interpret information shown by instruments, such as temperature, pressure, vacuum, or flow indicators, recorders or controllers and make corrective adjustments as required on equipment, based upon information obtained.
• Must keep accurate Batch Log Record Sheets showing materials used, produced and pertinent operating information such as pressure, temperature, and vacuum. Accurately labels containers ie. drums, bottles.
• Performs simple analytical tests such as pH, foreign matter, Ash test, LOD, and Kf. Also be able to use the mobile EHS monitor (Draeger Tube) and obtains samples from batches or containers and submits these samples to supervisor or laboratory computerized log in system.
• Keeps other employees aware of changes in the immediate environment (ie. welding, construction, critical process steps.
• Immediately informs the Supervisor of deviations in the process and completes deviation forms as required.
• Carries out all work as instructed by the Supervisor, assists when investigations have to be conducted, and takes immediate action in case of emergencies.
• Disposes of wastes in a correct manner and is responsible for good housekeeping and cleanliness at workstation.
• Performs necessary equipment maintenance as needed to support and continue batch processing.
• Safely drives and handles fork and hand trucks in the plant.
• Assists with the validation / qualification of processes and equipment and proposes improvements to the processes and equipment.
• Aims at the highest possible productivity considering all relevant safety, environmental and quality (cGMP) regulations and guidelines. Knows and follows all relevant Standard Operating Procedures.
• Adheres to personal moral, ethical, legal, and behavioral conduct in compliance with the Siegfried Code of Conduct.
• All other duties as assigned.
Your profile
EDUCATION and EXPERIENCE REQUIREMENTS:
• HS Diploma or equivalent is required.
• Must be able to read and write legibly in English and perform mathematical calculations such as yield and scale-down batch ratios.
• Prior bulk pharmaceutical experience or batch chemical experience is required.
• Must be able to work accurately and according to written and verbal instructions.
• Must be able to work in a chemical manufacturing plant environment.
• Must be able to obtain respiratory clearance.
• Must also be clean-shaven to wear a face respirator when required.
• Must be able to do heavy physical work and climb stairs. The heavy physical work consists of breaking and rolling drums that can weigh up to 400 lbs. Frequency: every shift
ADDITIONAL SKILLS and QUALIFICATIONS:
• Must be able to learn and operate computer-controlled equipment.
• Having additional computer skills is a plus.
• Must be able to operate in-plant vehicles.
• Must be able to load kettles, which requires the operator tips and lifts drums that weight up to 75 lbs. Frequency: every shift.
• Must be able to unloading centrifuges, which requires the operator to scrape cake off the cloth walls and scoop out the material that can weigh up to 5 lbs per scoop. Frequency every shift.
• Ability to stand for long periods.
• Able work in extreme temperatures, indoors when required to wear appropriate flame retardant uniform, coveralls or vapor barrier coveralls.
• Must be able to work overtime
Siegfried USA will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions.
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 Pennsville
Pennsville is our drug substance manufacturing site for the US mar-ket and provides spray drying operations globally.
Main activities
- Pilot and commercial manufacturing of drug substances (APIs) and related intermediates
- All fully cGMP and SHE compliant
Features
- 3 GMP pilot suites: 0.1–2 m³ reactors
- 200m3 commercial capacity: 1–10 m³ reactors
- Successful transfer of new products to the commercial scale - Powerful rectification
- Spray drying in pilot and commercial scale for both isolation and dispersion technology
- Micronization in pilot and commercial
Strategic importance
- CMO for innovative drug substances and manufacturer of our opiates portfolio for the US market