PositionSenior Technical Services Engineer
LocationVandalia, Ohio
SummaryThe Senior Technical Services Engineer is a critical member of the Manufacturing Science and Technology team, and will focus on supporting commercial products. The main activities will be scale-up, technology transfer, process development, process optimization, process validation, troubleshooting, deviations, failure investigations, and technical writing. The Scientist will also participate in Lean Manufacturing and Operational Excellence projects.
Responsibilities- Manage scale-up, technology transfer, and process development of commercial products, manufacturing feasibility batches, writing batch records, protocols, and summarizing results for both internal and 3rd party manufacturing.
- Develop and execute studies for process, equipment, and activities related to bulk drug delivery and finished dosage formulations developed by Research and Development (R&D) and products currently in commercial production to Adare, customer, and regulatory (domestic and foreign) requirements.
- Support Manufacturing through process optimization, troubleshooting, deviations and failure investigations, batch record revisions, and report writing. Supports Manufacturing, Quality Assurance, and Regulatory Affairs in technical issues.
- Provide product impact assessments for deviations and investigations to QA and Regulatory Affairs.
- Technical writing: Write experimental protocols, process validation protocols, summary reports, batch records, deviations, and investigations.
- A main contributor and practitioner of Lean Manufacturing and Op Ex programs within the facility.
- Technical experience and/or expertise in the operation of pharmaceutical equipment including but not limited to tablet presses, blenders, fluid beds, roller compactors, pan coaters, mixers, drying ovens, capsule fillers, packaging equipment, and other pharmaceutical equipment.
- Operate independently and provide feedback and solutions to technical issues for both internal projects and projects at 3rd party sites.
- Provide technical training and support to departments supported by the Validation and Technical Services department (Third party GSQ, Manufacturing, etc.).
- Other duties as assigned
Experience, Education, and Skills Required- BS/BA degree from a four-year accredited university or college in Biology, Chemistry, Engineering, or related field; plus 5-8 years of related experience required.
- Ability to continually learn on the job: new equipment, new manufacturing technologies, new raw materials, etc.
- Problem solving and trouble-shooting abilities. Ability to determine the root causes of failures and problems.
- Capable of scientific observation of processes; has ability to accurately record observations and draw conclusions from them.
- Technical writing ability. Ability to explain scientific and technical issues to a non-specialist audience.
- Good working knowledge of "Good Manufacturing Practices".
- Excellent interpersonal written and oral communication skills.
- Proficient in Microsoft Office - Word, Excel, PowerPoint, Visio. Experience with statistical software such as JMP is desirable.
- Ability to coordinate, contribute to, and work within cross-functional teams.
- Able to prioritize duties and work on multiple projects with minimal supervision.
- Possesses good attention to detail and excellent organizational skills.
- Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.
- Works in a cooperative manner with managers, supervisors, coworkers, customers, and the public.
- Works effectively under deadlines.
