Crosslink Manufacturing Sr. Technician 2nd Shift 1:00pm-9:30pm
About The Position
The Crosslink Manufacturing Senior Technician performs routine and non-routine activities and procedures required for cross-linked hyaluronic acid product production. The role follows established procedures in daily work and uses judgment to resolve basic issues or make recommendations. Assignments are moderately difficult; the technician normally receives little instruction on daily work and general instructions on newly introduced assignments. This is a second-shift position, with hours of 1:00 p.m. to 9:30 p.m. The technician operates production equipment and performs production, cleaning, sterilization, changeover, documentation, and troubleshooting activities in a biotechnology or pharmaceutical manufacturing environment.
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, enter biotechnology or pharmaceutical manufacturing areas, and wear personal protective equipment such as 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 procedures associated with cross-linked hyaluronic acid product production.
- Follow written work instructions to perform solvent recovery, 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 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 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
Senior
Education Level
High school or GED
