Senior Manufacturing Technician (Crosslink)

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

Job summary

Join a leading company in medical equipment manufacturing as a Senior Manufacturing Technician. You will be responsible for the production of cross-linked hyaluronic acid while ensuring compliance with Good Manufacturing Practices. The role requires strong problem-solving skills and the ability to work in a cGMP environment, making it ideal for those with experience in medical device manufacturing.

Qualifications

• 4-6 years experience in a cGMP manufacturing environment is essential.
• Strong communication and computer skills are required.
• Experience in medical device manufacturing is a plus.

Responsibilities

• Operates production equipment according to SOPs and Batch Records.
• Executes procedures related to production and performs troubleshooting.
• Records data and ensures compliance with documentation practices.

Skills

Strong communication skills

Proficiency in computer skills

Ability to gown and work in biotech/pharma areas

Ability to lift 25-50 lbs

Ability to stand for 6 hours

Ability to climb ladders

Education

High school diploma, GED, or equivalent

Tools

Microsoft Office

ERP/SAP

Job description

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Position Scope:

The Sr. Crosslink Technician performs routine and non-routine activities and procedures required for cross-linked hyaluronic acid product production. The position follows established procedures in the execution of daily activities and uses judgment in resolving basic issues or making recommendations.

Specific Tactical Responsibilities:

• Operates production equipment according to Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MD), and Manufacturing Operating Procedure (OPM)
• Executes procedures related to cross-linked hyaluronic acid production
• Performs solvent recovery, clean out of place, clean in place of equipment and components
• Performs scheduled cleaning and sterilization of equipment
• Supports changeover activities
• Troubleshoots process issues
• Initiates work orders and reviews documentation for compliance
• Coordinates sample preparation and testing
• Records data into Batch Records, log books, and OPMs
• Documents work activities per Good Documentation Practices and suggests revisions
• Reports deviations and nonconformance
• Assists in Quality System tasks and maintains floor metrics
• Maintains current training on procedures

Job Complexity:

Works on moderately difficult assignments requiring judgment. Receives minimal daily instructions and general guidance on new tasks.

Supervisory Responsibilities:

None

Required Qualifications:

• High school diploma, GED, or equivalent
• 4-6 years experience in a cGMP manufacturing environment
• Flexible work hours
• Strong communication skills
• Proficiency in computer skills and Microsoft Office
• Ability to gown and work in biotech/pharma areas with PPE
• Ability to lift 25-50 lbs and stand for 6 hours
• Ability to climb ladders and work around chemicals

Desired Skills and Experience:

• Experience in medical device manufacturing
• Experience in clean rooms or aseptic techniques
• Experience with automated equipment and ERP/SAP

Additional Details:

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Industries: Medical Equipment Manufacturing