Validation Engineer I - Process Validation

Merck KGaA Darmstadt Germany - St. Louis, MO

Full-time - Entry Level

St. Louis, MO

Chemical Manufacturing

About the position

In the role of Validation Engineer I - Process Validation at MilliporeSigma, you will be reporting to the Head of MSAT. This position is pivotal in developing, reviewing, and managing the execution of validation activities. As a Validation Engineer I, you will provide technical leadership within cross-functional teams, taking on the primary responsibility as a subject matter expert in the strategy for process validation of unit operations within Bioconjugation and Bio Organics facilities. Your role will involve defining and implementing a comprehensive process validation framework, ensuring that consistent process qualification, process validation, and continuous process verification (CPV) strategies are in place. You will be tasked with defining the strategy for executing process performance qualification (PPQ) and overseeing the product life cycle. This includes generating, reviewing, and approving process validation protocols and reports. You will lead the development of studies related to process hold time, homogeneity, mixing, and more. Additionally, you will establish drug substance/API manufacturing process control strategies and assess process performance by monitoring and analyzing process/product data. Your responsibilities will also include leading process validation-related investigations and collaborating closely with clients and personnel from various departments such as Manufacturing, Process Development, Process Sciences, Quality Control, Quality Assurance, Operations, and Project Management to ensure that scientific and CMC strategies are robust and maintained. Maintaining compliance with applicable regulatory requirements is crucial in this role. You will manage data, generate Process Validation/CPV documents, and organize, manage, and interpret data while performing detailed data analysis. As a process validation subject matter expert, you will participate in audits and customer meetings as needed. The ideal candidate will be a self-starter with the ability to manage their workload with minimal supervision and drive projects forward through collaboration and sound decision-making.

Responsibilities

• Define and implement process validation framework.
• Implement consistent process qualification, process validation and continuous process verification (CPV) strategies.
• Define strategy for execution of process performance qualification (PPQ) and product life cycle.
• Generate, review, and approve process validation protocols and reports.
• Lead development of studies around process hold time, homogeneity, mixing etc.
• Lead establishment of drug substance/API manufacturing process control strategies and assess process performance by monitoring and analyzing process/product data.
• Lead process validation related investigations.
• Work closely with the client and personnel from Manufacturing, Process Development, Process Sciences, Quality Control, Quality Assurance, Operations, and Project Management to ensure the scientific and CMC strategies are robust and maintained.
• Maintain compliance with applicable regulatory requirements.
• Data Management, Generation of Process Validation/CPV documents.
• Organizes, manages, and interprets data, performs detailed data analysis.
• Process Validation SME in audits and customer meetings as needed.
• Self-starter with ability to manage workload with minimal supervision.
• Ability to drive projects forward with collaboration and making sound decisions.

Requirements

• Bachelor's Degree in Engineering (Chemical Engineering, Mechanical Engineering, etc.) or Life Science (Chemistry, Biology, etc.)
• 1+ years of experience in Validation or 1+ year of experience in a GMP Environment.

Nice-to-haves

• 2+ years of experience/ SME level of understanding with manufacturing, process validation, Process Performance Qualification (PPQ) and Continued Process Verification (CPV)
• Ability to utilize GDP during document creation and review
• Comfortable in a fast-paced environment with the ability to adjust to changing priorities.
• Flexibility and accountability
• Experience working with current regulatory guidelines and standards.
• Experience working with pharmaceutical standards, rules, and guidance (e.g., FDA, EU, ISO, ISPE, etc.)

Benefits

• Diversity and inclusion initiatives
• Opportunities for professional development
• Support for career growth
• Access to a broad range of backgrounds and perspectives