Overview
Candidates will have experience in process development support primarily to new product introductions (NPI) and lifecycle management (LCM). This is a product lead role where the majority of input provided will be leading of process performance qualification (PPQ). The successful candidate will be expected to provide technical support to biologics drug product manufacturing as part of the global Process Development organization. If successful the applicant will report to Process Development Senior Engineer. Moderate international travel might be required during the course of the project.
Key Responsibilities
- Development of validation plans, process performance qualifications for vial and syringe filling.
- Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
- Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer.
- Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.
- Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
- Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance
Qualifications
- Third level Bachelor's degree in science/engineering or a relevant quality discipline with 5 years' experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Problem solving ability and excellent oral and written communications skills.
- 5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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