Manufacturing Technician II (Crosslink)

Anika Therapeutics Inc.; Bedford (MA); On-site; USD 60,000 - 80,000; Full time

Job summary

A forward-thinking company in the medical equipment manufacturing sector is seeking a dedicated Manufacturing Technician II. This entry-level role involves operating production equipment and adhering to strict cGMP standards for cross-linked hyaluronic acid product production. You will be responsible for executing established procedures, troubleshooting process-related issues, and maintaining meticulous documentation. Ideal candidates will have a high school diploma and relevant experience in a cGMP environment. Join this innovative team and contribute to the production of high-quality medical devices that make a difference in people's lives.

Qualifications

• 2-4 years experience in a cGMP manufacturing environment.
• Ability to gown and work in biotechnology/pharmaceutical areas.

Responsibilities

• Operate production equipment and follow SOPs for product production.
• Perform scheduled cleanings and sterilization of equipment.
• Troubleshoot and resolve process-related issues.

Skills

cGMP experience

written communication skills

verbal communication skills

ability to work flexible hours

ability to lift 25-50 lbs

ability to work around chemicals

Education

High school diploma or GED

Tools

automated equipment

computerized transaction systems

Job description

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Position Scope:
The Crosslink Technician II has primary responsibility 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)

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

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Management and Manufacturing

Industries

• Medical Equipment Manufacturing