· Accurately complete documentation in batch records, logbooks, forms and other GMP documents.
· Sets up and operates production equipment to produce work in process and finished goods
· Take samples for further downstream testing and perform tests during processing according to standard procedures
· Check products on line to confirm proper assembly and remove defective products
· Cleans , maintains, and performs basic repairs on equipment as needed
· Use of ERP system for performing material transactions/moves/quantities/cycle counts
· Offer suggestions and follow up on process improvements related to safety, compliance, cost, yield and productivity.
· Carry out duties in compliance with all state and federal regulations and guidelines including FDA, TUV, EPA and OSHA.
· Adhere to the safety code of Conduct & EHS policies and attend all required EHS training.
· Overtime is required, as needed
· Needs to perform gowning procedures to work in manufacturing core or classified rooms
· While performing the duties of this job, the employee is required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms for extended periods of time
· Must be able to lift bulks, place on mixer and attach tubing to filling machine
· Close Visual Acuity (Visual inspection for small defects or parts, extensive reading or analyzing data).
· Intermediate Visual Acuity (operating machines, computer terminal or work at or within arm's reach).
· Perform other work-related duties as assigned
Quals--
** 2nd Shift 3pm-11:30PM M-F **
Job Summary:
This position is responsible for performing manufacturing procedures and executing diverse tasks in a manufacturing area related to Filling. According to detailed operational specifications and execution of scheduled tasks within a cGMP environment. Ensure materials are available to meet production schedule. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations. Accountable for adhering to all EHS guidelines. This is a 2nd Shift Opportunity (3pm-11:30pm M-F).
The Opportunity:
We are seeking a Manufacturing Operator II. This position is responsible for performing manufacturing procedures and executing diverse tasks in a manufacturing area related to Filling. According to detailed operational specifications and execution of scheduled tasks within a cGMP environment. Ensure materials are available to meet production schedule. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations. Accountable for adhering to all EHS guidelines.
The Individual:
• High School Diploma required; Bachelor's Degree preferred
• 3 years of experience in medical device or pharmaceutical manufacturing preferred
• Experience using SAP is preferred
• Proficient with using MS Office (Word, Excel, Outlook)
• Strong mechanical problem-solving ability and technical aptitude.
• Ability to work independently with limited supervision and work as part of a team
• Able to solve practical/complex problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to demonstrate flexibility and adaptability, as well as prioritize within a changing business environment
• Must pass vision acuity test for inspection of work in process and finished goods
• Ability to occasionally lift up to 40lbs.
• Strong communication, intrapersonal and written skills.
The Work Environment
The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. The employee is required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms for extended periods of time. Is frequently required to communicate with coworkers. Ability to lift-up to 40lbs. Work with blood, blood products and chemicals. Periodic exposure to 2-8°C temperature controlled cold box during product transfer.
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.