Nova Biomedical is hiring a Controls Filling Operator III in our Waltham, MA facility on the Second Shift (3:00 PM - 11:30 PM - This includes a 10% Shift Differential). The Controls Filling Operator III will be responsible for performing filling, sealing, and labeling and packaging of various ampule and vial controls by means of written and/or verbal instruction. They will also be responsible for recording all pertinent information as required in various assembly procedures and logs.

Other Responsibilities and Accountabilities Include:

• Set up per procedure and equipment specification for controls filling operation.
• Operating and monitoring of controls filling equipment - load/unload product, assure product is properly filled, sealed, labeled, and quarantined as required.
• Documentation - accurate and complete record of control filling and packaging procedure.
• Perform set up and in-process testing and tonometry during filling process.
• Maintenance of Controls filling area and equipment including daily cleaning, cleaning between batches, periodic maintenance/calibration work orders.
• Train and guide junior and controls filling operators.
• Assist in SAP transactions, as needed.

Qualifications:

• Read and write English and follow written/verbal instructions.
• Performs basic math and counting.
• Solid mechanical aptitude.
• Working knowledge of Quality System Regulations (QSR).
• Working knowledge of OSHA safety standards.
• Working knowledge of Good Manufacturing Practice (GMP).
• Basic knowledge of waste management as it relates to controls operation.
• Physical Demands:
  • Must be able to perform tasks that may involve for extended periods of time standing, sitting, pushing, pulling, lifting, bending, kneeling, reaching, twisting, turning, climbing steps and carrying up to 40 pounds several times/hours a day
  • Require repetitive use of arms/wrist/hands while setting up/working with equipment/computer throughout the day
  • Will require use of Personal Protective Equipment (PPE) and may include, but not limited to, safety glasses, safety shoes, lab coat, bouffant, gloves, hearing protection, face shield, nuisance mask.
  • Must have good hand/eye coordination and visual acuity
  • Must be able to distinguish color

Skills and Competencies:

• Controls Filling Operator II skills.
• Ability to work with hand tools and gauges to operate filling/packaging equipment such as vial fill/plug/cap system/shrink bander, ampule filler/labeler/auto traying system, syringe filler/labeler and sterilizers/autoclave.
• Willingness to learn ability to adapt to change, and a positive attitude.
• Ability to operate manual pallet jacks.
• Must be able to work as part of a team or individually.
• Basic knowledge of SAP.
• Basic knowledge of computers and MS Office.
• Good written and verbal communication and leadership qualities.

Education/Experience:

• High School Diploma or equivalent
• 2-4 years' experience in machine operation is required. Pouch/Bottle/Ampule filling experience preferred.
• 2-4 years' experience in a Good Manufacturing Practice (GMP) environment is required.
• 0-2 years' experience with tonometry is desired.
• 0-2 years' expereince with SAP or equivalent is desired.

At Nova Biomedical, we practice our core values of mutual respect, honesty, and integrity throughout the company. With a strong sense of family in the workplace, we are proud that one third of all our employees have been with us for over 10 years.

Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, company subsidized cafeteria and an innovative scholarship program for children of employees.