Work Schedule

Environmental Conditions

Job Description

Work Schedule:

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

Set-Up Technician – Encapsulation (Night Shift)

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.

DESCRIPTION

How Will You Make an Impact?

The Set-Up Technician will be responsible for the proper set-up, changeover, adjustment, and operation support of encapsulation equipment to ensure safe, efficient production of quality products. This position works closely with Operators and Lead Operators to prepare equipment for production, troubleshoot equipment issues, perform required checks and adjustments, and ensure equipment and documentation meet applicable quality and cGMP requirements.

A Day in the Life:

• 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:

• Required: 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.

What We Offer:

Compensation:

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

Excellent 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