About The Position

The Crosslink Technician II is primarily responsible for activities and procedures required to produce cross-linked hyaluronic acid products. The position follows established procedures when performing daily work and receives instructions for new assignments. Work is routine in nature and requires cGMP experience; routine assignments are performed according to procedures, with instruction and training provided for new assignments.

Requirements

  • High school diploma or GED, or equivalent experience.
  • At least 2 years of related experience in a cGMP manufacturing environment.
  • Ability to work flexible hours to complete work activities.
  • Written and verbal communication skills.
  • Ability to gown and enter biotechnology or pharmaceutical manufacturing areas, and wear personal protective equipment such as safety glasses or goggles, gloves, and safety shoes.
  • Ability to lift, pull, or push equipment requiring up to 25–50 pounds.
  • Ability to stand for 6 hours in a production suite.
  • Ability to climb ladders and work platforms.
  • Ability to work around chemicals, including alcohols, acids, and bases.

Nice To Haves

  • Manufacturing experience in the medical device industry.
  • Experience working in a clean room or using aseptic technique.
  • Experience using commercial-scale automated equipment.
  • Ability to perform computerized transactions and maintain spreadsheets.

Responsibilities

  • Operate production equipment according to Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MD), and Manufacturing Operating Procedures (OPM).
  • Execute procedures associated with cross-linked hyaluronic acid product production.
  • Follow written work instructions for solvent recovery and clean-out-of-place and clean-in-place activities involving complex equipment and components.
  • Perform scheduled equipment cleaning and sterilization.
  • Support changeover activities.
  • Troubleshoot and resolve process-related issues.
  • Record data in Batch Records, logbooks, and OPMs.
  • Review logbooks and forms.
  • Document work activities according to Good Documentation Practices.
  • Report procedural deviations and nonconformance to management.
  • Maintain current training on assigned procedures, including read-and-understood, skills development, and classroom training as required.

Benefits

  • Discretionary bonus program for full-time employees.
  • Comprehensive healthcare benefits.
  • Health savings account.
  • 401(k) plan with up to 5% company match and immediate vesting.
  • Employee stock purchase plan at a 15% discount.
  • Accrued paid time off.
  • Long-term incentives, including stock awards.
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