Crosslink Manufacturing Technician: 2nd Shift 1:00pm-9:30pm
About The Position
The Crosslink Technician II is primarily responsible for activities and procedures required for the production of cross-linked hyaluronic acid products. The role follows established procedures in daily work and receives instructions for new assignments. Work is routine in nature and requires cGMP experience; new assignments require instruction and training. The position operates production equipment and performs production, cleaning, sterilization, changeover, troubleshooting, and documentation activities in accordance with applicable procedures and records. The technician maintains current training on assigned procedures and reports procedural deviations and nonconformances to management.
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 to perform solvent recovery, clean-out-of-place, and clean-in-place activities for 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 nonconformances 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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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
