Production Operator 2

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.

A Production Operator 2 is expected to manufacture products in accordance with supplied Standard Operating Procedures, adhering to Good Manufacturing Practices, in a clean, controlled environment. Maintaining accurate raw material inventories and adhering to the Quality Policy. Other responsibilities include drafting/revising documentation, training new hires, conducting critical equipment qualification/validation, and supporting projects/new product launch.

• Manufacture product per SOP as directed by the production planner
• Prepare and submit samples to the appropriate QC department
• Ensure adherence to GMP guidelines for IVD manufacturing

• Transfer and issue consumed raw materials to batches via the MRP system
• Maintain thorough, up-to-date production & accounting forms
• Review completed batch records for GMP/GDP compliance
• Monitor inventory of raw materials
• Train production personnel on relevant process and procedures

• Monitor inventory of general laboratory supplies
• Maintains laboratory equipment and document maintenance activities
• Participate in the qualification/validation of new equipment
• Oversee the routine housekeeping of the production area, cleaning process equipment, etc.
• Keeping equipment on a preventative maintenance schedule

• Write or edit standard operating procedures (SOPs) for repetitive manufacturing activities
• Work with Quality Assurance to develop SOP’s required as part of the GMP process
• Support the resolution of deviations, investigations, non-conformances, and other Quality issues

• Bachelor’s degree in a laboratory technology field (i.e. Chemistry, Biology) or 3+ years of production experience as a high level Chemical Operator/Technician (or equivalent)
• 2+ years’ experience as Chemical Operator/Technician
• Organizational and documentation skills and general problem solving ability
• Good interpersonal skills and an ability to provide effective work direction
• Excellent written and verbal communication skills
• Computer skills appropriate for work responsibilities

Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.  

Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program.

Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.