Senior Manufacturing Technician, 1st Shift (Aseptic)
Anika · Bedford, MA · 2 mo ago
ManagementFull-time
What You’ll Do
- Operates production equipment according to Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MD), and Manufacturing Operating Procedures (OPM).
- Executes all procedures associated with aseptic fills (transfer, set-up, sanitization, autoclaving, process simulation, etc.).
- Performs scheduled cleaning and sterilization of equipment.
- Supports changeover activities.
- Troubleshoots and resolves process-related issues.
- Initiates work orders.
- Reviews manufacturing documentation for compliance.
- Captures and reviews sample preparation and testing.
- Records data into Batch Records, log books, and OPMs.
- Documents all work activities according to Good Documentation Practices and recommends document revisions.
- Reports procedural deviations and nonconformance to management.
- Aids the Lead Technician in quality system generation, reviewing log books and non-critical forms, and maintaining floor metrics.
What It Takes
- High school diploma or GED, or equivalent experience.
- 4–6 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 computer skills and Microsoft Office applications.
- Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas and wear personal protective equipment such as safety glasses/goggles, gloves, and safety shoes.
- Ability to lift, pull, or push 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.
- Ability to work flexible hours to complete work activities.
Nice to Have
- Mechanical aptitude.
- 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.
Pay
The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more.