Manufacturing Technician III/Lead Wed to Sat 3:30 PM to 2AM

PCI Pharma Services•Bedford, NH

8d•Onsite

About The Position

The Manufacturing Technician III/IV leads others in complex manufacturing tasks under general guidance, following manufacturing instructions, current GMP/ISO requirements, and PCI safety guidelines. The technician leads and performs manufacturing operations for biopharma and medical device products, including equipment preparation, dispensing, dissolution, formulation, purification, aseptic compounding, filling, and packaging. The role addresses non-routine matters, uses technical knowledge to resolve complex manufacturing problems, monitors personnel interactions, escalates issues requiring management resolution, and works with, reviews, and revises master production records and standard operating procedures. The technician trains and guides less experienced personnel and models PCI’s Guardian values and behaviors. This position leads a team of manufacturing technicians, assigns daily tasks, maintains schedules, and helps ensure scheduled work is completed. It involves preparing solutions and equipment, performing aseptic filling and labeling, operating processing and filling equipment, maintaining production documentation, troubleshooting issues, and ensuring compliance, cleanliness, and orderliness in operational areas. The role works with cross-functional support teams and may require adapting to changing processes, client scrutiny, and adjusted work hours based on business needs. The stated schedule is Wednesday through Saturday, 3:30 PM to 2:00 AM. The role is based at the Bedford manufacturing site at 25 Commerce Drive, where the product mix creates a dynamic and complex work environment. Travel is less than 10%.

Requirements

2–4 years of experience in the pharmaceutical or medical device industry; finished-dose-form experience preferred.
Strong knowledge of aseptic techniques and fill-finish experience required.
Experience reviewing and creating controlled documents.
High school diploma required.
Ability to weigh and measure raw materials and operate basic benchtop instruments.
Ability to plan and prioritize complex activities to meet goals and objectives.
Strong analytical skills to identify risks and make balanced decisions.
Excellent organizational, verbal, and written communication skills.
Detail-oriented with strong mechanical aptitude.
Positive attitude and interpersonal skills to resolve and de-escalate issues.
Honesty, integrity, respect, and courtesy in interactions with leadership and peers.
Commitment to conducting business according to high legal and ethical standards and pursuing excellence in manufacturing and delivery of products and services.
Resilience and ability to move forward through complexity and unexpected events, with a willingness to take on challenges and improve skills.
Ability to work independently as a self-starter and handle multiple priorities in a dynamic, cross-functional team environment.
Ability to wear personal protective equipment, including safety glasses or goggles, gloves, and safety shoes.
Ability to gown and enter controlled manufacturing areas.
Ability to lift, pull, or push equipment requiring up to 25–50 pounds of force.
Ability to stand for six hours in a production suite.
Ability to work shifts of up to 10 hours as required by business needs.

Nice To Haves

Finished-dose-form experience in the pharmaceutical or medical device industry.

Responsibilities

Maintain safe work habits and follow PCI safety procedures and guidelines; identify safety risks and alert management.
Lead the team in completing daily tasks, maintain the daily and weekly schedule, and provide direction to team members.
Complete daily tasks and report or escalate issues to management.
Work with management to support a positive culture within operations.
Mentor less experienced staff in aseptic techniques.
Prepare solutions; perform aseptic filling and vial labeling under sterile and non-sterile conditions; conduct solution preparation and filtration; and prepare and sterilize vials and components.
Assemble, disassemble, and operate aseptic filling and lyophilizer equipment in classified cleanrooms and controlled non-classified environments; operate vial cappers and liquid fill lines and unload product from lyophilizers.
Prepare equipment and components for sterilization and lyophilization.
Operate processing equipment, including autoclaves, ovens, vial washers, depyrogenation equipment, centrifuges, and mills.
Assist with product formulation and dispensing in cleanroom environments according to SOPs and MBRs.
Sanitize production areas and prepare equipment for production.
Complete, maintain, and review work documentation, including logbooks and batch records.
Train team members and ensure required training is completed before assigning tasks.
Troubleshoot and resolve equipment or process problems encountered while performing job duties.
Follow verbal instructions and written procedures when operating equipment and performing processing steps, and accurately complete production documentation.
Identify, escalate, and document deviations from normal operations; perform investigations as needed.
Maintain compliance, cleanliness, and orderliness in operational areas according to applicable SOPs.
Perform COP, CIP, and SIP operations to prepare equipment for manufacturing.
Build, clean, and sterilize equipment to support production operations, applying understanding of sanitization and sterilization practices.
Participate successfully in media fills and aseptic proficiency tests.
Interact with cross-functional support teams, including Operations, QA, QC, Engineering, R&D, and Validation.
Raise personnel-related issues to management for resolution.
Adapt to changing processes and adjust work hours as needed based on business needs.