Manufacturing Technician IV/Lead

About the role

As a Manufacturing Technician IV at PCI, you will lead others in complex manufacturing tasks under general guidance, adhering to current GMP/ISO requirements and safety guidelines. This role involves performing and overseeing operations such as equipment prep, dispensing, formulation, purification, aseptic compounding, filling, and packaging for biopharma and medical device products. You will address non-routine matters, resolve complex manufacturing problems, and mentor less experienced personnel while modeling PCI’s Guardian values and behaviors.

Responsibilities

• Maintain and adhere to safe work habits and PCI safety procedures; proactively identify safety risks.
• Lead a team to accomplish daily tasks, maintain schedules, and provide direction.
• Prepare solutions, perform aseptic filling and labeling of vials, and conduct routine solution and filtration.
• Assemble, disassemble, and operate aseptic filling equipment and lyophilizers in cleanroom and controlled environments.
• Operate vial cappers, unload products from lyophilizers, and prepare equipment for sterilization.
• Sanitize production areas and prepare equipment for production.
• Complete, maintain, and review documentation, including logbooks and batch records.
• Train and ensure proper training within the team prior to assigning tasks.
• Troubleshoot and resolve equipment or process problems; escalate deviations from normal operations.
• Perform COP, CIP, and SIP operations to prepare equipment for manufacturing.
• Demonstrate understanding of sanitization and sterilization practices.
• Inspire a positive culture and mentor less experienced staff in aseptic techniques.
• Participate in media fill/aseptic proficiency tests.

Requirements

• High school diploma with 4+ years of cGMP pharmaceutical experience, including finished dose form.
• 4+ years of experience in the pharmaceutical or medical device industry.
• Strong knowledge of aseptic techniques and fill-finish experience.
• Experience in reviewing and creating controlled documents.
• Detail-oriented with strong mechanical aptitude.
• Positive attitude and strong interpersonal skills to resolve and de-escalate issues.
• Commitment to conducting business according to the highest legal and ethical standards.
• Ability to work as a self-starter and handle multiple priorities in a dynamic, cross-functional team environment.

Skills

• Exceptional organizational skills and attention to detail.
• Proficiency in MS Office (Word, Excel).
• Ability to work in a fast-paced environment with minimal supervision.
• Strong analytical skills to identify risks and make balanced decisions.
• Excellent verbal and written communication skills.
• Ability to weigh and measure raw materials and operate basic benchtop instruments.
• Resilience through operational and organizational change.

Special Demands

• Ability to wear personal protective equipment (safety glasses/goggles, gloves, safety shoes).
• Ability to gown and enter controlled manufacturing areas.
• Ability to lift, pull, or push equipment requiring up to 25-50 lbs of force.
• Ability to stand for 6 hours in a production suite.
• Ability to work any shift (up to 10 hours) as required by business needs.
• Ability to read, understand, follow, and comply with technical and written documents (SOPs) in English.
• Ability to communicate effectively using speech, vision, hearing, and written word.
• Interaction with cross-functional teams such as Operations, QA, QC, Engineering, R&D, and Validation.