Senior Production Operator (SPO) II, 12 Hour Night Shift

Role Summary

The Senior Production Operator II is responsible for the proper operation and maintenance of assigned production equipment, performing routine preventative maintenance and operation of the equipment during manufacturing. This role also acts as a coach/trainer for others and SME for process operations related to the production equipment within the respective area.

Responsibilities

• Self-motivated with ability to work in a team environment and independently.
• Work in a clean manufacturing environment, requiring special garments to be worn. Demonstrated proficiency in gown/de-gown (aseptic) process.
• Responsible for the proper operation of production equipment, equipment downtime, and scrap rate.
• Perform machine set-up, repairs, adjustments, changeovers, emergency repair/replacement, and preventative maintenance on production equipment per applicable procedures.
• Interact and interpret data from production equipment automated control systems and displays.
• Adhere to all safety requirements (PPE, LOTO, etc.) and process step requirements (SOP, Batch Records).
• Communicate and inform management of all safety issues, quality issues, and equipment repair plan of action recommendations.
• Communicate effectively with team members and management to achieve production deliverables and schedule adherence.
• Support Integrated Manufacturing Excellence (IMEx) activities (CI, SW, TPM) including tracking metrics.
• Demonstrated proficiency in cGMP, Good Documentation Practice, and following detailed instructions.
• Demonstrated proficiency working with automated production equipment.
• Demonstrated proficiency in troubleshooting and root cause analysis.
• Certified Trainer; coaches and trains new hires.
• SME of the production equipment within the respective area.

Qualifications

• Required: High School Diploma (or Equivalent).
• Required: 2+ years of pharmaceutical manufacturing experience.
• Required: Problem solving mindset.
• Required: Possess mechanical skills to perform machine set-up, repairs and adjustments to keep equipment operating efficiently.
• Required: Proficiently operate/maintain standard maintenance tools/equipment including basic hand and power tools, multi-meters, and other mechanical equipment.
• Required: Ability to read, interpret, and perform duties described in operating procedures, product batch records, and other equipment-related documentation (vendor manuals, P&ID, schematics, drawings, etc.).
• Preferred: 3+ years of relevant pharmaceutical manufacturing experience as operator/mechanic.
• Preferred: Technical school/auto mechanic program certificate and/or industrial maintenance/repair experience.

Education

• High School Diploma (or Equivalent) required.

Additional Requirements

• Stand 8-12 hours per shift; sit 2-4 hours per shift; use computer terminal ~1 hour per shift.
• Change into area required garments (scrubs, shoes, PPE, safety glasses) 2-3 times per shift.
• Work around moving/rotating equipment, chemicals; hear in hearing conservation area; occasional kneeling or non-standing positions for repairs.
• Respond to visual/audible warnings and alarms; respond to color or other visual indicators.
• Walk on floors/catwalks; climb stairs/ladders.
• Must be able to lift up to 50 pounds.
• Shift is 12 hours nights, Mon-Fri varies with a dedicated day off; typical start/end time 6pm to 6am; ability to work overtime as required.