Technical Operations Engineer

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.

Innovating every day.

• Manage activities at CMOs pertaining to qualification/validation of equipment, processes, and cleaning. Typical activities would include (but not limited to) raw material and component assessments on process/product, process development/optimization, scale-up and cleaning validation.
• Monitor feasibility, engineering, registration and validation batches at CMO to ensure that all process steps are within critical process parameter requirements.
• Perform troubleshooting activities to identify root cause and implement corrective and/or preventative actions for product issues at CMOs.
• Review manufacturing and packaging batch records for products that are manufactured at CMOs.
• Review equipment qualification, process development, process validation and cleaning validation protocols, including design of appropriate testing procedures and evaluation criteria.
• Review final report packages to ensure that the study complies with test and protocol requirements.
• Maintain a positive working relationship with Cosette peers and CMO team members to facilitate the completion of assignments.
• Communicate the status of project activities and possible issues that may impact the progress of projects to manager, project teams and other management, as needed.
• Review technical documentation to support regulatory filings and product launches such as batch records, process descriptions, etc., as needed.
• Prepare and update Standard Operating Procedures (SOPs) as needed.
• Other duties as assigned by the Vice President, Technical Services/3rd Party Operations.

• Minimum B.S. Degree in Engineering, Chemistry (or related life science) with 3+ years of related experience in oral solid dosage forms.
• Proficiency in the following functional areas of expertise: process development, scale-up and process validation.

• Prior experience in pharmaceutical manufacturing, validation, quality assurance, or process control / practices is required.
• Knowledge of current Good Manufacturing Practices (cGMPs) and applicable government regulations is required.
• Good written and oral communication skills is required. Knowledge of Good Documentation practices is required.
• Knowledge of statistical evaluation and problem-solving skills is required.

Equal Opportunity Employment

Providing "equal employment opportunity" is one of the most important people policies of Cosette Pharmaceuticals, Inc. Our goal is to do all that we realistically can to provide genuine equal employment opportunity to applicants and employees in all phases of our operation. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual's race, creed, religion, color, national origin, citizenship, ancestry, age, gender identity or expression, affectional or sexual orientation, marital status, domestic partnership, familial status, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, liability for service in the United States armed forces or any other legally protected status. The Company is dedicated to ensuring that all employment decisions are in accordance with these principles of equal employment opportunity.