Job Summary

The Sr. Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing. The Sr. Process Engineer’s responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.
• Writes Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests, etc.
• Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed.
• Author manufacturing investigations and complete CAPA assignments.
• Composes process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols.
• Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products.
• Interact with clients during routinely scheduled project meetings.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in Engineering, Pharmacy, or Chemistry.
• 5 years of experience of technical support in a sterile pharmaceutical manufacturing environment.
• Previous experience supporting tech transfer of parenteral Drug Products preferred.

Knowledge, Skills, and Abilities

• Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills required.
• Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes.
• Working knowledge of EU regulations preferred.
• Proficiency with Microsoft office (Word, Excel, Outlook) required.
• Ability to interact with internal stakeholders and external customers.

Travel Expectations

• Up to 5% domestic travel.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to frequently stand, walk, sit; talk or hear; use hands to finger, handle or feel. The employee is required some of the time to reach with hands and arms. The employee is required occasionally to climb or balance; and taste or smell. The employee must frequently lift and/or move up to 25 pounds. There is no special vision requirement for this job. The employee may occasionally work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals.