Set-Up Technician - Encapsulation - Nights

About the role

As part of the Pharma Services Group (PSG), the High Point, NC site focuses on gelatin-based drug delivery dosage forms (softgels). We offer extensive development and commercial-scale capabilities for a variety of softgel technologies.

Responsibilities

• Reviews the production schedule and products at the beginning of the shift to understand production requirements and prepare for upcoming equipment changeovers.
• Checks the operation of encapsulation lines at the start of the shift and periodically throughout the shift to ensure equipment is operating properly and product quality requirements are maintained.
• Sets up and adjusts encapsulation equipment according to approved procedures, product requirements, and established operating parameters.
• Prepares for, assists with, and executes equipment changeovers, ensuring the correct materials, tooling, parts, and equipment are available.
• Completes required changeover documentation and obtains appropriate approvals before equipment is released for production.
• Reviews production paperwork for completeness and accuracy and verifies that required in-process and quality checks are completed and documented according to applicable procedures and work instructions.
• Monitors product quality and equipment performance and makes appropriate machine adjustments as needed.
• Communicates equipment adjustments and operating changes to Lead Operators and Operators to maintain consistent product quality and equipment performance.
• Troubleshoots equipment and assists Lead Operators and Operators in identifying the cause of machine problems and making appropriate repairs or adjustments.
• Cleans and prepares equipment as required and verifies equipment is visually clean and properly documented before use.
• Assists with cleaning and maintaining the Encapsulation production area.
• Assists in training Operators on equipment operation, set-up, changeovers, adjustments, and troubleshooting to support team performance and knowledge development.
• Uses measuring instruments and basic hand tools as required to complete equipment set-up, adjustment, and troubleshooting activities.
• Performs Operator duties as needed to support production requirements.
• Adheres to all applicable safety, quality, cGMP, and site procedures.
• Performs other reasonable, related business duties as required.

Requirements

• Education: High school diploma or equivalent required.
• Experience:
  • Minimum of 3–4 years of work experience in a manufacturing, operations, production, mechanical, or related environment.
  • Preferred: Experience operating, setting up, changing over, or troubleshooting manufacturing equipment.
  • Preferred: Experience working in a cGMP-regulated manufacturing environment.
• Knowledge, Skills, Abilities:
  • Demonstrated mechanical aptitude and ability to troubleshoot manufacturing equipment.
  • Ability to use measuring instruments and basic hand tools.
  • Ability to read, understand, and follow written procedures, work instructions, safety requirements, operating instructions, and production documentation.
  • Ability to accurately complete production records, logbooks, check sheets, and other required documentation.
  • Ability to perform basic mathematical calculations involving time, volume, weight, fractions, decimals, percentages, ratios, and proportions.
  • Ability to interpret operating information and make appropriate equipment adjustments within established procedures.
  • Strong attention to detail and ability to remain focused on assigned tasks.
  • Ability to plan ahead and organize work to support production schedules and equipment changeovers.
  • Effective verbal and written communication skills.
  • Ability to work effectively with Operators, Lead Operators, supervision, Quality, and other supporting functions.
  • Ability to understand and follow management and supervisory direction.
  • Ability to work a 12-hour shift in a 24-hour, 7-day-per-week operation.
  • Must meet applicable DEA security clearance requirements if requested.
  • Must be able to work overtime as necessary.

Physical Requirements / Work Environment

• Must be able to frequently lift, push, pull, and carry up to 50 pounds.
• Position requires regular use of hands to handle equipment, tooling, and materials and may require overhead lifting and reaching.
• Position may require standing, stooping, kneeling, crouching, crawling, walking, climbing, and balancing while performing equipment set-up, cleaning, adjustment, and troubleshooting activities.
• Work is performed around moving mechanical equipment and may involve vibration, wet or humid indoor conditions, and moderate to loud noise.

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) and Safety Standards.
• Cleanroom requirements apply, including restrictions on hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, and other prohibited items.
• Work may involve loud equipment/machinery, strong odors, and hazardous/toxic materials.
• Required Personal Protective Equipment (PPE) may include safety glasses, gowning/uniform or lab coat, gloves, safety shoes, hair protection, and hearing protection.
• The position may require the use of a respirator and compliance with applicable respiratory protection requirements.

Schedule

• 12-hour shift/nights, 7:00 p.m. – 7:00 a.m. (2-2-3 schedule).

Benefits

• Medical, Dental, & Vision benefits – effective Day 1
• Paid Time Off & Designated Paid Holidays
• Retirement Savings Plan
• Tuition Reimbursement
• Employee Referral Bonus
• Career Advancement Opportunities

Pay

• Competitive Hourly Pay Rate
• Additional shift differential for night shift positions, where applicable
• Annual performance-based bonus
• Annual merit performance-based increase