Manufacturing Technician IV - Lead

About the role

The Manufacturing Technician IV leads others in a variety of complex tasks under general guidance, following current GMP/ISO requirements, PCI safety guidelines, and the manufacturing instruction set. With general supervision, the technician leads and performs all manufacturing operations—including equipment preparation, dispensing, dissolution, formulation, purification, aseptic compounding, filling, and packaging for biopharma and medical‑device products. The role addresses non‑routine matters, utilizes technical knowledge to resolve complex manufacturing problems, monitors personnel interactions, escalates issues to management, reviews and revises master production records and standard operating procedures, and trains and guides less‑experienced personnel while modeling PCI’s Guardian values and behaviors.

Responsibilities

• Maintain and adhere to safe work habits and all applicable PCI safety procedures and guidelines.
• Proactively identify safety risks and alert management to take corrective action.
• Lead the team to accomplish daily tasks and keep the weekly/daily schedule up to date.
• Provide direction to the team, be accountable for completing daily tasks, and report issues to management.
• Work with management to foster a positive operational culture.
• Mentor less‑experienced staff in aseptic techniques.
• Prepare solutions, perform aseptic filling and labeling of vials under sterile and non‑sterile conditions, and handle routine solution filtration, vial and component preparation, and sterilization.
• Assemble, disassemble, and operate aseptic filling and lyophilizer equipment in classified cleanrooms and controlled non‑classified environments.
• Operate vial capper, unload product from lyophilizers, and manage the liquid fill line.
• Prepare equipment and components for sterilization and lyophilization.
• Operate processing equipment such as autoclaves, ovens, vial washers, depyrogenation units, centrifuges, and mills.
• Assist in formulation and dispensing of product in a clean‑room environment per SOPs and MBRs.
• Sanitize production areas and prepare equipment for production.
• Complete, maintain, and review documentation related to assigned work, including logbooks and batch records.
• Train team members and ensure proper training before assigning tasks.
• Troubleshoot and resolve equipment or process problems.
• Follow verbal instructions and written procedures, accurately completing production documentation.
• Identify, escalate, and document deviations from normal operation; perform investigations as needed.
• Maintain compliance, cleanliness, and orderliness of operational areas per SOPs.
• Perform COP, CIP, and SIP operations to ready equipment for manufacturing.
• Demonstrate understanding of sanitization and sterilization practices.
• Inspire a great workplace and uphold the quality of PCI’s people, products, and clients.
• Participate successfully in media‑fill/aseptic proficiency tests.
• Raise personnel‑related issues to management for resolution and assign daily tasks.
• Lead a team of manufacturing technicians to complete scheduled activities.

Qualifications

• High school diploma.
• 4+ years of cGMP pharmaceutical experience, including finished dose‑form work.
• 4+ years of experience in the pharmaceutical or medical‑device industry.
• Strong knowledge of aseptic techniques and fill‑finish experience.
• Experience reviewing and creating controlled documents.
• Detail‑oriented with strong mechanical aptitude.
• Positive attitude and strong interpersonal skills for issue resolution and de‑escalation.
• Honesty, integrity, respect, and courtesy with leadership and peers.
• Commitment to the highest legal and ethical standards and continuous excellence in manufacturing.
• Resilience and ability to move forward despite challenges.
• Self‑starter capable of handling multiple priorities in a dynamic, cross‑functional team environment.
• Exceptional organizational skills and attention to detail.
• Proficiency in Microsoft Office (Word, Excel).
• Ability to work in a fast‑paced environment.
• Creative, independent thinker with minimal supervision.
• Ability to weigh and measure raw materials and operate basic benchtop instruments.
• Strong planning and prioritization skills for complex activities.
• Analytical skills to identify risks and make balanced decisions.
• Excellent verbal and written communication skills.

Work Environment

Employees must wear personal protective equipment (safety glasses/goggles, gloves, safety shoes) and gown to gain entry to controlled manufacturing areas. The role requires the ability to lift, pull, or push equipment weighing up to 25–50 lb, stand for up to six hours in a production suite, and work any shift (up to 10 hours) as business needs dictate. The position demands reading, understanding, and complying with technical and written documents (SOPs) in English, and effective communication using speech, vision, hearing, and written word. Interaction with cross‑functional support teams—including Operations, QA, QC, Engineering, R&D, and Validation—is routine.

Physical Demands

• Capability to perform duties with or without reasonable accommodations.
• Ability to lift, pull, or push equipment up to 25–50 lb.
• Standing for up to six hours in a production