Crosslink Manufacturing Sr. Technician 1st Shift 6:00am-2:30pm
About The Position
The Crosslink Manufacturing Senior Technician performs routine and non-routine activities and procedures required for production of cross-linked hyaluronic acid products. The role follows established procedures for daily activities and uses judgment to resolve basic issues or make recommendations. Work assignments are moderately difficult; the technician normally receives little instruction on daily work and general instructions for newly introduced assignments. The technician operates production equipment and executes manufacturing procedures in accordance with standard operating procedures, batch records, manufacturing directions, and manufacturing operating procedures. The role includes equipment cleaning and sterilization, changeovers, troubleshooting, documentation review, sample coordination, and support for quality-system activities. The position requires maintaining current training and complying with written work instructions and good documentation practices.
Requirements
- High school diploma or GED, or equivalent experience.
- At least 4 years of related experience in a cGMP manufacturing environment.
- Ability to work flexible hours to complete work activities.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office.
- Ability to gown and enter biotechnology or pharmaceutical manufacturing areas and wear personal protective equipment, including safety glasses or goggles, gloves, and safety shoes.
- Ability to lift, push, or pull equipment requiring up to 25–50 lbs and stand for up to 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.
- Experience with ERP systems, preferably SAP.
Responsibilities
- Operate production equipment according to Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MD), and Manufacturing Operating Procedures (OPM).
- Execute all procedures associated with cross-linked hyaluronic acid product production.
- Follow written work instructions for solvent recovery and clean out of place (COP) and clean in place (CIP) of complex equipment and components.
- Perform scheduled equipment cleaning and sterilization.
- Support changeover activities.
- Troubleshoot and resolve process-related issues.
- Initiate work orders.
- Review manufacturing documentation for compliance.
- Coordinate sample preparation and testing.
- Record data in Batch Records, log books, and OPMs.
- Document work activities according to Good Documentation Practices and recommend document revisions.
- Report procedural deviations and nonconformance to management.
- Assist the Lead Technician with quality-system generation, review of log books and non-critical forms, and maintenance of floor metrics.
- Maintain current training on assigned procedures, including read-and-understood, skills development, and classroom training activities 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 with 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
Senior
Education Level
High school or GED
