The Engineer will be part of a manufacturing functional team. The focus will be on discrepancy management, identifying and implementing remediation with a cross functional team. The position requires proficiency in facilitation of investigations, analytical thinking toward identifying root cause, teamwork, collaboration to identify and implement solutions, technical writing capabilities to write clear and concise quality records. The position requires skill and knowledge in Technical Writing, Quality Systems and RCA Methodologies
Responsibilities:
- Manage the deviation end-to-end process as owner in accordance with procedures, performance measures, and standard lead times.
- Notify management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- Effectively facilitate cross-functional discussions associated with investigation’s cause, remediation and impact analysis.
- Manage the remediation as owner (if necessary), working collaboratively across several functions to achieve timely closure.
- Manage assignments that are complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
- Identify and solve the problems proactively.
About You:
- At least a degree in a relevant science/engineering discipline.
- At least 5-7 years of relevant experience in the pharmaceutical industry.
- Exhibits good knowledge of international cGMP and compliance requirements.
- Strong technical writing skills.
- Display a good level of problem solving ability and provide suggestion/alternative solutions on complex issues resolution.
- Displays strong interpersonal, exceptional teamwork and collaboration skills.
- Highly motivated, well organized and able to develop alternate solutions to issues.
- Ability to communicate clearly and professionally in both writing and verbally.
- Experience with mammalian/bacterial biopharmaceutical production strongly preferred.
