Responsibilities :
- Document and execute equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment and end-of-line processes.
- Creation of manufacturing work instructions.
- Interface with customers on technical issues, project timeline, and validation support.
- Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations.
- Provide support for operations and communicate with Program Managers.
- Provide training of operations personnel.
- Depending on level of position, could lead projects of moderate scope and duration or independently perform work, which can include creating, maintaining, and communicating projects.
- Task purpose, scope, schedule, team roles and responsibilities.
- Plan, schedule, and conduct or coordinate detailed phases of the engineering work for projects.
Requirements :
- Bachelor's degree in engineering required.
- Depending on level of position - years relevant experience.
- Strong technical writing to develop client process validations.
- Excellent communication skills.
- Excellent attention to detail, analytical and problem-solving skills.
- Strong knowledge of statistics.
- Experience with IQ, OQ and PQ protocols.
- Knowledge of GMPs.
- Depending on level of position - Ability to work independently, ability to initiate and manage communications with customer, ability to negotiate with clients regarding projects, timelines, and processes, develop systems to improve standard processes.
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