Chemical Manufacturing Technician I - API Manufacturing

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 to safeguard and support ET’s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

Benefits

• Leading pay and annual performance bonus for all positions
• Generous paid time off including 14 paid holidays
• Health, Dental, and 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

About the Role

Operate API manufacturing equipment to achieve production goals.

Responsibilities

• Maintain chemical inventories
• Follow instructions listed in GMP documentation & product quality and provide suggestions for improvements as needed
• Read and understand SOPs, Job Instructions (JIs) & other documents, as required and challenge topics to develop knowledge
• 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 Operations Area Lead and Shift Supervisor
• Setup, operate, monitor, control, highly automated processes & systems with assistance of more senior technicians
• Clean, assemble and dismantle processing equipment
• Handle bulk and drummed flammable solvents with oversight from more senior technicians
• Handle drummed highly hazardous acids and bases with oversight from more senior technicians
• Handle sensitizing agents, peptides, small molecule API’s and intermediates with oversight from more senior technicians
• Execute production schedule to achieve production goals
• Assist in troubleshooting 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
• Maintain clean room areas & perform environmental monitoring, as required with oversight from seasoned technicians
• 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
• 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
• 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
• 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 color vision based on role
• Occasionally ascends/descends a ladder
• May be required to work at elevated heights
• 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 extreme heat / cold work environments depending on site
• Occasionally works around odorous &/or hazardous materials
• May be required to wear latex gloves
• 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 lift license & operate lift based on the role

Qualifications

• High School Diploma or GED and a minimum of one (1) year of manufacturing experience in a chemical manufacturing environment required, preferably in a pharmaceutical manufacturing environment
• In lieu of a High School diploma and one (1) year of experience, may consider an Associate’s Degree in Engineering Technology or a Science-related field from an accredited college or university
• Computer literacy including, but not limited to, 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 perform basic material handling tasks, safely & effectively use material handling equipment required
• Basic knowledge of biology/chemistry required

Preferred Skills and Experience

• API Manufacturing experience
• Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & fact to include actively participating in event response activities, documenting problems & ensuring rapid resolution & preventing recurrence
• Experience following SOPs to perform tasks & raising issues if errors are found
• Experience following established safety guidelines when performing tasks
• 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
• Experience with filtration of products using various types of filtration equipment, centrifugation of materials, chromatography, and drying of materials under heat and vacuum
• Experience with Process Safety Management (PSM) systems and ability to identify safety concerns & improvement
• Experience in ensuring compliance with corporate/local SOPs, regulations & ISO standards
• General knowledge in current Good Manufacturing Practices (cGMP) manufacturing & production processes associated with pharmaceutical companies
• Mechanical aptitude, ability to follow use tools to perform tasks, basic troubleshooting of mechanical components & systems preferred
• Experience working with work permits/Lock Out Tag Out (LOTO) systems
• Experience with DeltaV and general automation software, including general troubleshooting of these systems & working with support groups to resolve issues