Chemical Manufacturing Technician II - Active Pharmaceutical Ingredients
Novo Nordisk
About the Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Our new Petersburg, Virginia site marks a strategic move to advance our capabilities within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support SMOL projects and API production in the coming years, aligning with our vision and strengthening our potential for growth and innovation. What we offer you:
Essential Functions
- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance - effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
Essential Functions
- Role model for working in a safe and environmentally responsible manner
- Maintain chemical inventories
- Follow instructions listed in GMP documentation & product quality and provide suggestions for improvements as needed
- Review SOP's, Job Instructions (JI's) & other documents, as required
- Real-time review of batch records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards
- Manage individual training plan with assistance of API Operastions Area Lead and Shift Supervisor
- Execute qualification documents such as IQ, OQ, PQ documentation in addition to other validation activities with assistance of more senior technicians
- Independent handling of:
- Bulk and drummed flammable solvents
- Drummed highly hazardous acids and bases
- Sensitizing agents, peptides, small molecule API's and intermediates
- Ability to operate while using advanced personal protective equipment (PPE) including but not limited to air hoods, full face respirators, cartride respirators, and chemical suits
- Clean, assemble and dismantle processing equipment
- Setup, operate, monitor, & control highly automated processes & systems
- Troubleshoot during equipment maintenance, including restoration of lost function, predictive & preventive maintenance
- Participate in deviation investigations
- Load & unload product from trucks, tankers & ISO containers, as required
- Execute production schedule to achieve production goals
- Maintain clean room areas & perform environmental monitoring, as required
- Assist with training and onboarding new employees
- Perform Lock Out Tag Out (LOTO) activities in accordance with safety procedures with assistance of more senior technicians
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities as assigned
- High School diploma or GED and a minimum of three (3) years of manufacturing experience required in a chemical manufacturing environment required, preferably in the pharmaceutical industry
- In lieu of a High School diploma and three (3) years of experience, may consider an Associate's Degree in Engineering Technology or a Science-related field from an accredited college or university with a minimum of one (1) year of manufacturing experience in a chemical manufacturing environment required, preferably in a pharmaceutical manufacturing environment
- Experience following SOPs to perform tasks & raising issues if errors are found required
- Experience following established safety guidelines when performing tasks required
- Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts to include actively participating in event response activities, documenting problems & ensuring rapid resolution & preventing recurrence required
- Computer literacy including, but not limited to the ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs required
- Ability to read & understand complicated product documentation & standard operating procedures with attention to detail required
- Ability to write technical product documents required
- Ability to operate while using advanced personal protective equipment including but not limited to air hoods, full face respirators, cartridge respirators, and chemical suits with oversight from more senior technicians required
- Experience in and ability to ensure compliance with corporate/local SOPs, regulations & ISO standards required
- General knowledge in current Good Manufacturing Practices (cGMP) manufacturing & production processes associated with pharmaceutical companies preferred
- Basic knowledge of biology/chemistry required
- Advanced mechanical aptitude required
- Mechanical aptitude, ability to follow use tools to perform tasks, basic troubleshooting of mechanical components & systems required
- Other preferred skills and experience:
- API experience
- Experience with operation, troubleshooting, & training less experienced personnel in large scale reactor unit operations including but not limited to, pressure and vacuum inertions, distillations, refluxing of solvents, separation of bi-phasic systems and pH adjustments using acids and bases. In addition, experience with filtration of products using various types of filtration equipment, centrifugation of materials, chromatography, and drying of materials under heat and vacuum
- Ability to perform basic material handling tasks & safely & effectively use material handling equipment preferred
- Experience with Process Safety Management (PSM) systems. Ability to identify safety concerns & improvement
- Experience with chemical handling, chemical reactions, centrifugation and packaging of bulk materials fermentation, centrifugation, chromatography, buffer/media prep
- Experience working with work permits/Lock Out Tag Out (LOTO) systems. Experience leading LOTO activities & training less experienced staff preferred
- Experience with Delta V PCS/MES/SAP, general automation software preferred
- Experience with DeltaV and general automation software. Experience with general troubleshooting of these systems & working with support groups to resolve issues preferred
Vacancy posted 5 days ago
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