Manufacturing Technician II

Position Scope:The Crosslink Technician II has primary responsible for the activities and procedures required for cross linked hyaluronic acid product production. The position follows established procedures in the execution of daily activities and receives instructions on new assignments.Specific Tactical Responsibilities:Operates production equipment according to Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MD), and Manufacturing Operating Procedure (OPM)Executes all procedures associated with cross linked hyaluronic acid product production Adheres strictly to written work instructions to perform solvent recovery, clean out of place, clean in place of complex equipment and componentsPerforms scheduled cleanings and sterilization of equipmentSupports change over activitiesTroubleshoots and resolves process related issuesRecords data into Batch Records, log books and OPM'sReviews Logbook and FormsDocuments all work activities according to Good Documentation PracticesReports procedural deviations and nonconformance to managementMaintains current training on all assigned procedures to include read & understood, skills development and classroom training activities as required Job Complexity:The position works on assignments that are routine in nature where cGMP experience is required to perform work activities. The Crosslink Manufacturing Technician II normally follows procedures on routine work, requires instruction and training on new assignments. Supervisory Responsibilities:NoneRequired Qualifications:High school diploma, GED or equivalent experience2-4 years related experience in a cGMP manufacturing environmentAbility to work flexible hours to complete work activitiesMust possess written and verbal communication skillsAbility to gown and gain entry to biotechnology/pharmaceutical manufacturing areas; ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoesAbility to lift, pull or push equipment requiring up to 25-50 lbs; ability to stand for 6 hours in a production suiteAbility to climb ladders and work platformsAbility to work around chemicals (alcohols, acids & bases)Ability to work flexible hours to complete work activitiesDesired Experience, Knowledge, and Skills:Manufacturing experience in a medical device industryExperience working in a clean room or using aseptic technique Experience using commercial scale automated equipmentAbility to perform computerized transactions and maintain spreadsheets are a plus

Created: 2025-02-08