Senior Biological Technician (Wednesday Saturday)

Shift: Wednesday - Sunday

Key Responsibilities

Advanced Production & Laboratory Operations

Manufacture biological indicator components in accordance with cGMP procedures including but not limited to:

• Spore seeding and inoculation;

• Agar pour plate preparation and testing;

• Preparation of subassemblies and raw materials;

• Harvesting and washing activities;

• Perform inprocess and release testing including:

  • Percent spore determination;

  • Purity testing;

  • Titer testing

Equipment Area and Process Ownership

• Perform and oversee preventative maintenance and basic troubleshooting of laboratory equipment in accordance with approved SOPs

• Ensure daily area housekeeping and sustained GMP readiness

• Manage routine laboratory processes and ensure required checks and verifications are completed accurately and on time

• Conduct inventory reconciliation material restocking and SAP transactions as required

Documentation Compliance & Investigations

• Prepare review and verify batch records and production documentation in accordance with cGDP requirements

• Support investigations deviations inspections and root cause analysis activities as directed

• Ensure personal and team compliance with all Federal State local and Company regulations policies and procedures

Technical Leadership & Training

• Train and mentor juniorlevel technicians in accordance with approved manufacturing procedures and standard work

• Participate in and actively support process improvement initiatives including Kaizen 5S and efficiency projects

• Communicate operational risks issues and improvement opportunities to supervision and management

• Safety Communication & General Responsibilities

• Support a strong safety culture and ensure proper use of PPE and safe laboratory practices

• For individuals with informal or formal leadership responsibilities ensure work is performed in compliance with Health Safety and Environmental requirements

• Perform other duties as assigned to support business needs

Education and Experience Requirements

• 6 years of relevant laboratory or biologics manufacturing experience or 2 years of experience with a Bachelors degree in a related scientific discipline.

• High School Diploma or GED required.

• Bachelors Degree in Biology Microbiology or a related scientific discipline preferred

• Strong working knowledge of cGMP and cGDP requirements

• Advanced laboratory skills in aseptic processing and biologics manufacturing

• Experience working in an FDAregulated manufacturing environment

• Proficiency with SAP or similar inventory management systems

• Basic computer skills (word processing and spreadsheets)

• Yellow Belt certification preferred

• Domestic travel may be required

• Ability to lift 3150 lbs

• Ability to wear required PPE

• Ability to work in a manufacturing laboratory environment