Crosslink Manufacturing Technician II

Location: Bedford, MA

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 components
  • Performs scheduled cleanings and sterilization of equipment
  • Supports change over activities
  • Troubleshoots and resolves process related issues
  • Records data into Batch Records, log books and OPM’s
  • Reviews Logbook and Forms
  • Documents all work activities according to Good Documentation Practices
  • Reports procedural deviations and nonconformance to management
  • Maintains 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:

None

Required Qualifications:

  • High school diploma, GED or equivalent experience
  • 2-4 years related experience in a cGMP manufacturing environment
  • Ability to work flexible hours to complete work activities
  • Must possess written and verbal communication skills
  • 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 & bases)
  • Ability to work flexible hours to complete work activities

Desired Experience, Knowledge, and Skills:

  • Manufacturing experience in a 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 are a plus

We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.