Manufacturing Technician II (Crosslink)

Anika; Bedford (MA); On-site; USD 45,000 - 65,000; Full time

Job summary

A leading company in the healthcare industry is seeking a Manufacturing Technician II to join their team. This entry-level position involves operating production equipment for cross-linked hyaluronic acid products, adhering to strict cGMP standards, and performing various manufacturing tasks. The ideal candidate will have a high school diploma and experience in a cGMP environment, with strong communication skills and the ability to work flexible hours.

Qualifications

• 2-4 years of related experience in a cGMP manufacturing environment.
• Ability to work flexible hours and lift up to 50 lbs.
• Experience working in clean rooms or with aseptic techniques is desired.

Responsibilities

• Operate production equipment according to SOPs and perform scheduled cleanings.
• Troubleshoot process-related issues and document work activities.
• Support changeover activities and maintain training on assigned procedures.

Skills

Communication

Problem Solving

Flexibility

Education

High school diploma or GED

Job description

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Position Scope:

The Crosslink Technician II is primarily 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:

1. Operate production equipment according to Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MD), and Manufacturing Operating Procedures (OPM).
2. Execute all procedures associated with cross-linked hyaluronic acid product production.
3. Adhere strictly to written work instructions to perform solvent recovery, clean out of place, clean in place of complex equipment and components.
4. Perform scheduled cleanings and sterilization of equipment.
5. Support changeover activities.
6. Troubleshoot and resolve process-related issues.
7. Record data into Batch Records, log books, and OPMs.
8. Review Logbook and Forms.
9. Document all work activities according to Good Documentation Practices.
10. Report procedural deviations and non-conformance to management.
11. Maintain current training on all assigned procedures, including reading & understanding, skills development, and classroom training activities as required.

Job Complexity:

The position involves routine assignments where cGMP experience is required. The Crosslink Manufacturing Technician II typically follows procedures on routine work and requires instruction and training on new assignments.

Supervisory Responsibilities:

None

Required Qualifications:

• High school diploma, GED, or equivalent experience.
• 2-4 years of related experience in a cGMP manufacturing environment.
• Ability to work flexible hours to complete work activities.
• Must possess strong written and verbal communication skills.
• Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas; ability to wear PPE 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).
• Flexibility to work different shifts as needed.

Desired Experience, Knowledge, and Skills:

• Experience in manufacturing within the medical device industry.
• Experience working in a clean room or using aseptic techniques.
• Experience with commercial-scale automated equipment.
• Proficiency in computerized transactions and maintaining spreadsheets is a plus.

Additional Details:

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Management and Manufacturing
• Industries: Hospitals and Health Care, Non-profit Organizations, Government Administration