Validation Engineer

Found in: Appcast US C2 - 2 weeks ago

Westford, United States Novozen Healthcare LLC Full time

Responsibilities:

· You will directly be supporting the manufacturing process validation team and conducts risk assessments with quality management and oversight activities.

· Acts as a technical resource for support of systems and new product introduction

· Support a wide array of qualification activities related to manufacturing processes within a biopharmaceutical manufacturing facility.

· Place a strong emphasis on process validation and sterilization processes.

· Will work with equipment owners to any issues during IQ/OQ/PQ for equipment and systems.

· Provide direct support to the manufacturing process validation team, specifically for small molecule sterile injectable drug products.

· Supports the CAPA system by assisting with root cause analysis and corrective action planning

· Support the development and maintenance of cGMP compliant quality systems.

· Any previous experience with sterilized products, particularly sterile injectables, is highly desirable.

· Familiarity with Process Validation, including the submission of batch reports to regulatory agencies such as the FDA.

· Experience working in pharmaceutical manufacturing, particularly within a cGMP (current Good Manufacturing Practices) environment. Pharmaceutical and Medical manufacturing experience is required.

· Proficiency in authoring technical documentation within the context of cGMP.

· Experience in responding to regulatory inquiries and questions from multiple agencies, including the FDA

Required Skills:

· Bachelors or Master’s degree with 3-5 years of experience related field and Prior Experience as a Quality Validation Engineer in the Medical Device/ Pharma industry, to include:

· Performing Qualification and Validation of Facilities & Equipment within a cGMP environment. Prior experience validating Manufacturing.

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