Engineer Process Support

Description

The position would be supporting a specific project to qualify an existing sterile ophthalmic product in a new container closure system

In addition, this position will support multiple commercial driven projects from initial feasibility through implementation.

Lead projects in manufacturing process areas to achieve process efficiencies such as increase in process yield, quality improvements, cycle time / throughput, and cost reduction initiatives.

Gather and analyze process data using statistical process control methodology.

Develop action plan to increase process robustness, prevent product loss, and control quality impact.

Participate in process performance monitoring such as Track & Trend.

Responsible for providing technical support in the resolution of shop floor situations and executing assigned tasks as required by the operational area.

Lead investigations by following a structure problem solving approach and employing sound, scientific principles when identifying root cause and developing recommendations related to product and process.

Generate technical justification to support and / or document process deviations / investigations and determine impact in product quality, yield, and product registration.

Part of cross-functional team responsible for implementation of site projects / initiatives (continuous improvement, cost reduction, capacity increase, etc.) that lead to process remediation.

Project management of smaller team, short duration projects within larger projects.

Responsibility may include project coordination, monitoring, reporting, meeting management, and team communication.

Lead the implementation of process validation for operational changes, new raw materials, and introduction of new process / technology.

Generate technical justification determining impact of change and protocols / reports / manufacturing documents that support its execution.

Assist the execution of experimental, demonstration, and validation lots.

Maintain up-to-date product process documentation and assure they are in compliance with applicable procedures and regulations.

Writes justification memos and scientific reports of quality controls and manufacturing documents.

Provide scientific and technical support during regulatory audits and agency inspections.

Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of the EHS program.

Qualifications

BS or MS in Chemistry or Engineering (Chemical, Mechanical, Bio-chemical)

5-7 years' of technical experience in Process / Manufacturing / Project Engineering or similar role.

Technical knowledge in fundamentals of pharmaceutical liquid-solid dosage forms processing.

Effective verbal and written communication skills in English.

Sterile product support, aseptic process development (with hands on experience)

Experience with process validation and technology transfers

Experience with design control

Strong data analysis skills and experience (will be doing a lot of data mining)

Sterile GMP, Project Management, IND and BLA submission, Six Sigma.

Eyecare product ophthalmic experience with mfg or development

Benefits

Healthcare Insurance :

Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance :

Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance :

Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan : The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus :

Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.