Crosslink Manufacturing Sr. Technician 2nd Shift 1:00pm-9:30pm

Anika; Bedford (MA); On-site; USD 65,000 - 88,000; Full time

Benefits offered by this job

Discretionary bonus program

Comprehensive healthcare benefits

401(k) with up to 5% company match

Employee stock purchase plan

Paid time off and long-term incentives

Job summary

Anika is seeking a Senior Crosslink Manufacturing Technician for our Bedford, MA site to perform routine and non-routine activities for cross-linked hyaluronic acid production. You will follow established procedures and use judgment to resolve basic issues while contributing to continuous improvement.

You’ll operate equipment per SOPs, execute all production procedures, and maintain rigorous documentation. A strong background in cGMP manufacturing and safe handling in a biotech setting is

Qualifications

• High school diploma or GED, or equivalent experience.
• 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 gain entry to biotechnology/pharmaceutical manufacturing areas and wear PPE.
• Ability to lift, push, or pull equipment 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.

Responsibilities

• Operates production equipment according to SOPs, Batch Records, MDs, and OPMs.
• Executes all procedures for cross-linked hyaluronic acid production.
• Performs COP/CIP and cleaning of complex equipment and components.
• Performs scheduled cleaning and sterilization of equipment.
• Supports changeover activities.
• Troubleshoots and resolves process-related issues.
• Initiates work orders and reviews documentation for compliance.
• Coordinates sample preparation and testing.
• Records data into Batch Records, log books, and OPMs.
• Documents work activities per Good Documentation Practices; suggests revisions.
• Reports deviations and nonconformance to management.
• Assists Lead Technician with quality system generation and floor metrics.
• Maintains current training on all procedures, including read-and-understood, skills development, and classroom training.

Skills

cGMP manufacturing

Communication skills

Microsoft Office

Flexibility hours

Safety awareness

Education

High school diploma or GED

Tools

SAP

Job description

The Crosslink Manufacturing Senior Technician performs routine and non-routine activities and procedures required for cross-linked hyaluronic acid product production. This role follows established procedures in the execution of daily activities and uses judgment in resolving basic issues or making recommendations.

How You’ll Contribute

• Operates production equipment according to Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MD), and Manufacturing Operating Procedures (OPM).
• Executes all procedures associated with cross-linked hyaluronic acid product production.
• Adheres strictly to written work instructions to perform solvent recovery, clean out of place (COP), and clean in place (CIP) of complex equipment and components.
• Performs scheduled cleaning and sterilization of equipment.
• Supports changeover activities.
• Troubleshoots and resolves process-related issues.
• Initiates work orders.
• Reviews manufacturing documentation for compliance.
• Coordinates sample preparation and testing.
• Records data into Batch Records, log books, and OPMs.
• Documents all work activities according to Good Documentation Practices; recommends document revisions.
• Reports procedural deviations and nonconformance to management.
• Assists Lead Technician in quality system generation, reviewing log books and non-critical forms, and maintaining floor metrics.
• Maintains current training on all assigned procedures, including read-and-understood, skills development, and classroom training activities as required.

What It Takes

The position works on assignments that are moderately difficult, requiring judgment in resolving issues or making recommendations. The Senior Crosslink Manufacturing Technician normally receives little instruction on daily work and general instructions on newly introduced assignments.

What You Bring

• High school diploma or GED, or equivalent experience.
• 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 gain entry to biotechnology/pharmaceutical manufacturing areas and wear personal protective equipment such as safety glasses/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 Have

• Manufacturing experience in the medical device industry.
• Experience working in a clean room or using aseptic technique.
• Experience with ERP systems, preferably SAP.

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. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.

The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.