Senior MS&T Process Engineer II

Our Work Matters

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make: As a Senior MS&T Process Engineer II, you will play a critical role in supporting process validation activities and technology transfer initiatives within the Technical Operations organization. Working as part of the MS&T team, you will support the contract manufacturing business unit by leading and executing technical transfer and process validation projects for aseptic fill-finish pharmaceutical drug products.

In this role, you will design and execute process development studies, analyze complex manufacturing data, and author technical documentation, including validation protocols and reports. Your expertise in aseptic manufacturing, process validation, and technical transfer will support the successful commercialization of pharmaceutical drug products while ensuring compliance with CGMP and regulatory requirements. Through cross-functional collaboration with analytical, production, quality, and project management teams, you will help ensure the successful and timely delivery of manufacturing and validation milestones.

Responsibilities:

Process Development & Technical Transfer

• Act as a key technical lead for process development activities and independently design and manage studies supporting process development, optimization, scale-up, manufacturing records, and technology transfer.
• Independently design studies to evaluate the robustness of manufacturing processes and establish baselines for process validation activities.
• Evaluate complex process data and perform in-depth analysis using scientific principles to determine critical process parameters affecting process performance.
• Function as the Subject Matter Expert (SME) for manufacturing processes and technology transfer of new products related to process development.
• Execute experiments to support the development and characterization of new manufacturing processes.

Process Validation & Data Analysis

• Support process validation activities, including authoring protocols such as engineering runs and process performance qualifications.
• Independently review and analyze complex process data from clinical and commercial manufacturing batches to confirm process conformity and support batch release activities.
• Apply statistical and scientific analysis methods to evaluate manufacturing data and identify opportunities for process optimization.

Cross-Functional Collaboration

• Collaborate with analytical, production, quality, and project management teams to ensure the timely completion of project deliverables.
• Represent the Technical Operations department as a subject matter expert during meetings and conference calls with clients.
• Work with client technical staff, department leadership, and senior management to evaluate technical project requirements and define project scope.
• Guide junior personnel and contribute as an active member of cross-functional teams.

Technical Documentation & Compliance

• Author technical documentation, including protocols, reports, deviations, gap analyses, and risk assessments.
• Support the development of manufacturing production records and protocols supporting qualification, technical transfer, clinical manufacturing, and commercial production.
• Write and revise Standard Operating Procedures (SOPs) and batch records.
• Apply CGMP and GDP requirements across all areas of work.

Manufacturing Support & Investigation

• Provide technical support for fill-finish manufacturing activities, including OOS/OOT investigations, process deviation assessments, root cause analysis, and process optimization.
• Provide training to managers and production or laboratory staff regarding protocol requirements and new manufacturing processes.
• Work effectively with individuals across departments, including production, laboratory, engineering, and materials management.

Qualifications:

Basic Qualifications

• Bachelor’s degree in Science or Engineering with 7 years of relevant industry experience.
• Strong leadership skills with a high level of personal and departmental accountability.
• Strong understanding of process design principles.
• Experience with drug product manufacturing process development, process scale-up, and process optimization.
• Experience supporting sterile manufacturing operations, including aseptic processing or isolator technology.
• Strong analytical capabilities, including data evaluation, statistical analysis, and process control interpretation.
• Ability to manage multiple priorities in a dynamic environment and perform effectively under tight timelines.
• Excellent written and verbal communication skills with strong technical writing capability.
• Proficient knowledge of Current Good Manufacturing Practices (CGMP).
• Ability to exercise judgment when selecting methods and techniques to solve complex problems.
• Ability to work effectively across multiple departments and varying levels of experience.

Preferred Qualifications

• Regulatory experience supporting pharmaceutical development or research programs.
• Experience contributing to regulatory submissions.
• Demonstrated ability to independently determine work methods and procedures in complex technical situations.

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• Physical Requirements
• Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust and focus in order to read and execute documentation required by the position.
• Employees are required to follow all CGMP and safety procedures.
• Employees must wear required safety and protective equipment, including hearing, eye, and gowning protection, as required.
• Employees must perform assigned work safely and follow all departmental GMP and safety procedures.
• The employee may occasionally be required to lift or move up to 20 pounds.

Physical Requirements:

• Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust and focus in order to read and execute documentation required by the position.
• Employees are required to follow all CGMP and safety procedures.
• Employees must wear required safety and protective equipment, including hearing, eye, and gowning protection, as required.
• Employees must perform assigned work safely and follow all departmental GMP and safety procedures.
• The employee may occasionally be required to lift or move up to 20 pounds.

# LI-Onsite

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Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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