Title: Manufacturing Operator
Location: Raritan NJ
Duration: 1 Year
Schedule: This is a 2nd Shift Opportunity (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.
Responsibilities:
Execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum
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 arms reach).
Perform other work-related duties as assigned
Skills Required:
High School Diploma required; Bachelors Degree preferred but not mandatory
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.