Sr. Qualification Engineer (Scientist)
Bethlehem, PA 18015
The Scientist position encompasses all areas of Technical Services with primary focus on process and facility equipment qualification and secondarily providing process/packaging validation, cleaning validation and commercial production support.
- Lead and/or participate in project teams for process and facility equipment qualification, process/packaging validation, cleaning validation and commercial production support
- Coordinate process and facility equipment qualification activities to meet project/compliance due dates and product launch dates.
- Execute process and facility equipment qualification activities such as FATs, SATs, installation, operational and performance qualifications, equipment periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, CAPA, etc.
- Independently determine approaches to resolve complex technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques.
- Prepare, review, approve and/or execute documents to support projects and investigations such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, change control, etc.
- Provide process/packaging validation and commercial production support when needed such as protocol execution and batch monitoring, investigation of manufacturing incidents, qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, hold time studies, etc.
- Perform cleaning validation activities when needed such as execution of cleaning validation and verification studies, hold time studies, swab sampling, investigations, assessments, justifications, etc.
- Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.
- Represent Technical Services at project team meetings and provide sound technical advice.
- Coordinate and communicate with Operations, Facility Engineering and Quality Assurance groups and with clients and vendors to assure successful project execution and provide technical expertise.
- Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.
- Minimum of a Bachelor’s degree in a scientific discipline (e.g., Mechanical, Electrical or Chemical Engineering, Pharmaceutics or equivalent) with a minimum of 5 years experience in Process and Facility Equipment Qualification in Technical Services, Process Engineering, Facility Engineering or related field in the pharmaceutical industry.
- Experience in the qualification of instruments, laboratory and production scale process equipment, and facility equipment used in the manufacture of solid oral, liquid and semi-solid dosage forms such as moisture analyzers, automatic tablet testers, mills, high-shear granulators, fluid bed dryers, tablet presses, tablet film coaters, encapsulators, low and high-shear mixing vessels, homogenizers, pumps, packaging lines, utility systems and associated control systems, etc.
- Working knowledge of cGMP (Current Good Manufacturing Practices) regulations and general compliance expectations.
- Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment and impact evaluation.
- Must possess research and problem solving abilities and capable of producing detailed documentation, understand and make generalized and specific conclusions from project data.
- Technical writing experience is required with attention to detail skills essential.
- Must be able to work in a team environment with effective project planning/management, analytical thinking, organization, and execution skills.
- Demonstrated professionalism and excellent communication skills with internal and external personnel are essential.
- Ability to work effectively managing multiple projects independently at a fast pace with cross-functional departments and manage priorities to meet timelines.
- Must be Innovative, proactive, resourceful and committed to continuous improvement.
- Must have proficiency in the Microsoft Office Suite programs and working knowledge of PLC type of software.
- Working knowledge of cGMP electronic data management systems (e.g., ProCal, TrackWise, Oracle EAM) is preferred.