Lead Biopharma Manufacturing Technician (Aseptic)

PCI Pharma Services; Madison (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services in Madison, WI is seeking a Manufacturing Technician IV - Lead to supervise a team performing aseptic filling, solution prep, and lyophilization in controlled environments, ensuring GMP/ISO compliance and safe operation.

You will develop and revise master production records, train staff, and resolve complex manufacturing issues while maintaining documentation integrity and a culture of safety and quality.

Qualifications

• High school diploma with 4+ years 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.
• Integrity and commitment to PCI standards in business practices.
• Ability to work as a self-starter in a dynamic cross-functional team.

Responsibilities

• Lead team to accomplish daily tasks.
• Prepare solutions, aseptic filling and labeling of vials under sterile and non-sterile conditions.
• Assemble, disassemble and operate aseptic filling and lyophilizer equipment in cleanroom environments.
• Prepare equipment for sterilization and Lyophilization; operate autoclaves and related equipment.
• Assist in formulation and dispensing of product in a clean room per SOPs and MBRs.
• Train staff and ensure proper training before task assignments.
• Complete, maintain and review batch records and production documentation.
• Troubleshoot and resolve equipment or process issues and escalate as needed.

Skills

Aseptic techniques

Attention to detail

Strong interpersonal skills

Self-starter

Education

High school diploma + 4+ years cGMP experience

Tools

MS Office (Word, Excel)

Job description

PCI Pharma Services in Madison, WI is seeking a Manufacturing Technician IV - Lead to supervise a team performing aseptic filling, solution prep, and lyophilization in controlled environments, ensuring GMP/ISO compliance and safe operation.

You will develop and revise master production records, train staff, and resolve complex manufacturing issues while maintaining documentation integrity and a culture of safety and quality.