Our client, a leader in the biomedical industry, has an immediate opening for a Senior Crosslink Manufacturing Technician. This role will operate production equipment according to Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MD), and Manufacturing Operating Procedure (OPM).

Responsibilities:

• Execute all procedures associated with cross linked hyaluronic acid product production
• Adhere strictly to written work instructions to perform solvent recovery, clean out of place, clean in place of complex equipment and components
• Perform scheduled cleanings and sterilization of equipment
• Support change over activities
• Troubleshoot and resolve process related issues
• Initiate work orders
• Review manufacturing documentation for compliance
• Coordinate sample preparation and testing
• Record data into Batch Records, log books, and OPM’s
• Document all work activities according to Good Documentation Practices; recommend document revisions
• Report procedural deviations and nonconformance to management
• Assist Lead Technician in Quality System Generation, Reviewing Log Books and Non-Critical Forms, and maintaining floor metrics
• Maintain current training on all assigned procedures to include read & understood, skills development, and classroom training activities as required

Requirements:

• High school diploma, GED, or equivalent experience
• 4-6 years of related experience in a cGMP manufacturing environment
• Manufacturing experience in a medical device industry
• Ability to work flexible hours to complete work activities
• Must possess written and verbal communication skills
• Must be proficient in computer skills and Microsoft Office
• Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas; ability to wear personal protective equipment such as safety glasses/goggles, gloves, and safety shoes
• Ability to lift, pull, or push equipment requiring up to 25-50 lbs.
• Ability to stand for 6 hours in a production suite
• Ability to climb ladders and work platforms
• Ability to work around chemicals (alcohols, acids, and bases)
• Experience working in a clean room or using aseptic technique
• Experience using commercial scale automated equipment
• Experience with ERP, preferably SAP