API Manufacturing Associate I

Position Operate API manufacturing equipment to achieve production goals. Relationships Reports to Shift Manager, Operations – API. Essential Functions Work in a safe & environmentally responsible manner Follow instructions listed in GMP documentation & product quality Review SOP’s & other documents, as required Real time review of electronic batch records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards Manage individual training plan Participate in qualification & validation activities as required Setup, operate, monitor, & control highly automated processes & systems Load & unload product from trucks, tankers & ISO containers, as required Execute production schedule to achieve production goals Utilize investigation skills during troubleshooting & assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance Maintain clean room areas & perform environmental monitoring, as required 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 color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. 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 motorized vehicle license & operate a motorized vehicle based on the role. Qualifications High school graduate or equivalent required Associate's Degree or higher in Tech, Science, or Engineering preferred BioWork or equivalent industrial, military or vocational training combined with experience preferred Minimum two (2) years of manufacturing experience in FDA regulated environment preferred Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts. Actively participated in & driven event response activities. Documented problems & worked on ensuring rapid resolution & preventing recurrence preferred Experience following SOPs to perform tasks & raising issues if errors are found preferred Experience following established safety guidelines when performing tasks preferred 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 Ensure compliance with corporate/local SOPs, regulations & ISO standards required General knowledge in cGMP manufacturing & production processes associated with pharmaceutical companies required Basic knowledge of biology/chemistry preferred 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 systems preferred 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 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. #J-18808-Ljbffr Novo Nordisk