Manufacturing Process Technician

Job Summary:

• Analytical testing, characterization, sample and data management
• Equipment maintenance
• Contributes to team by ensuring the quality of the tasks/services provided by self
• Contributes to the completion of milestones associated with specific projects or activities within the team.
• Support manual visual inspection of filled units

Specific Job Duties:

• Plan and perform routine analyses with efficiency and accuracy.
• Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
• May perform aseptic aliquoting, sampling and analysis of compendia methods
• Prepare complete and accurate laboratory documentation following GMP guidelines.
• With a high degree of technical flexibility, work across diverse areas within the lab.
• Evaluate analytical data
• Perform general lab housekeeping
• Maintain/operate specialized equipment
• Comply with safety guidelines, GMPs and other applicable regulatory requirements
• Initiate and/or implement changes in controlled documents
• Troubleshoot, solve problems and communicate with stakeholders
• Participate in audits, initiatives, and projects that may de departmental or organizational in scope
• Evaluate lab practices for compliance and operational excellence improvements on a continuous basis
• May participate in lab/inspection investigations
• May provide technical guidance
• May train others
• May contribute to regulatory filings
• May represent the department/organization on various teams
• May interact with outside resources
• Support manual visual inspection of drug product filled units
• Deepens technical knowledge trough exposure and continuous learning

Basic Education:

• Bachelor’s Degree in Life Sciences & minimum 2 years of biopharma industry QC experience or related quality control or GMP laboratory experience
• Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products

Skills:

• Filling and finishing manufacturing experience, preferably vial inspection; understanding of measurements, calculations and the metric system; basic GMP knowledge
• Experience in GMP facility; Ability to perform tasks following standard operating procedures, protocols, and/or test plans comfort with electronic control systems (Delta V, MES)