Packaging Operator

Job Title:

Packaging Operator

Duration: 12 Months

Location:

Newark, DE

Pay - $22/hr on W2

• 1st shift: 6 AM to 4 PM
• 2nd shift: 3 PM to 11 PM
• 3rd shift: 11 PM to 7 AM

This position is responsible for producing packaged pharmaceutical products in a safe and efficient manner, complying with cGMP's, SOPs, and site safety procedures.

• Owns process and equipment performance by operating packaging equipment (tablet fillers, thermoformers, labelers, case packers, etc.) in a safe and efficient manner.
• Must understand and comply with cGMP's, SOPs and site safety procedures; also to follow good housekeeping rules.
• Verify correctness of product and components for the NDC packaged.
• Supply equipment with components and product; lifting requirements may be up to 30 lbs.
• Perform detection system challenges on applicable equipment.
• Perform maintenance activities including center lines and troubleshooting equipment jams.
• Responsible for visual inspection, cleaning (including quarterly cleanings) and tightening of equipment.
• Responsible to execute and improve changeover, assemble and disassembly, adjust equipment to optimize performance; provides direction on optimal sequence.
• Responsible for set up and first point of troubleshooting of packaging equipment and to document event forms or perform problem solving activities.
• Alert's supervision of any irregularities in procedures or equipment operations.
• Clean and purge packaging equipment.
• Accountable for accurately documenting packaging and cleaning activities in packaging worksheets, equipment cleaning logbooks, and within performance tracking systems (Traksys).
• Responsible of documenting and follow electronic batch record.
• Perform quality attribute inspections and in-process testing (torques, induction seal integrity, leak tests, appearance, etc.).
• Rework packages according to SOPs or rework packaging order to correct deviations.
• Attend regular SHE, GMP, PET and site meetings.
• Active participation and/or facilitation of line tier meetings to record performance, opportunities and recognize best practices.
• Share knowledge with co‑workers for training purposes.
• Work effectively in teams to meet monthly demand requirements.
• Identify areas for continuous improvement and efficiency improvements; participate in Kaizen and SMED events.
• Participate in deviation investigations and help drive to root cause using tools such as 5-Why; documentation of event worksheet.
• Accountable for line performance (OEE) and able to report hourly status of line to affected personnel to ensure timely resolution to issues (i.e. facilitators, engineers).
• Accountable for change‑over performance, MTBS, and metrics related to operations (SQSCP) following lean standards.
• Must be able to work other shifts, weekends, alternative schedules when production demands require; must be flexible to change; ability to perform duties with minimum supervision.
• Assist in the (re) qualification and (re) validation of processing equipment by supporting engineering in protocols and testing, and participate on factory acceptance test as required.
• Create and/or modify standard work cards and procedures (SOP).
• Responsible for recycling and waste management of line operations.
• Active participation on PET and site strategy initiatives.

In this role contractors must follow correct PPE guidelines outlined by the company.

Not permitted in Production Areas:

• Jewelry (includes non-smooth rings/bands, all body piercings, watches, necklaces, bracelets, fitness rings or watches with the exception of company approved medical accommodations)
• Cosmetics (includes all makeup, lipstick, false fingernails, fingernail polish (clear or color), false eyelashes and eyelash extensions)
• Food or beverages of any kind
• Personal medications of any kind
• Tobacco & Alcohol Products are not permitted at all on Site

Required in Production Areas (at a minimum, may require more depending on gowning level):

• Designated uniform to be worn while in production spaces
• Safety glasses, safety hard hat, hair net, beard cover (if applicable), safety shoes