About this role
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 in Emerging Technologies (ET) 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 ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.
What we offer you:
- 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
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Operate API manufacturing equipment to achieve production goals.
Relationships
Reports to Manager.
Essential Functions
- Maintain chemical inventories
- Follow instructions listed in GMP documentation & product quality and provide suggestions for improvements as needed
- Review SOP’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
- Execute qualification documents such as IQ, OQ, PQ documentation in addition to other validation activities with assistance of more senior technicians
- Clean, assemble and dismantle processing equipment
- Setup, operate, monitor, & control highly automated processes & systems
- Independent handling of bulk and drummed flammable solvents
- Independent handling of drummed highly hazardous acids and bases
- Independent handling of sensitizing agents, peptides, small molecule API’s and intermediates
- 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
Physical Requirements
Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Work around odorous &/or hazardous materials. Must have a high consciousness for personnel and equipment safety. Required to utilize a variety of personnel protective equipment. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.
Qualifications
- 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
- API experience preferred
- 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
- 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 preferred
- Experience with Process Safety Management (PSM) systems. Ability to identify safety concerns & improvement preferred
- Experience with chemical handling, chemical reactions, centrifugation and packaging of bulk materials fermentation, centrifugation, chromatography, buffer/media prep preferred
- 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
About Novo Nordisk
Global leader in diabetes care, obesity, and rare disease treatments using biologic therapies. Headquartered in Bagsvaerd, Denmark.
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