MS&T Engineer II

Kindeva Drug Delivery • Bridgeton, MO

2d • Onsite

About The Position

As an MS&T Process Engineer II, you will support 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 contributing to technical transfer and process validation projects for aseptic fill-finish pharmaceutical drug products.
In this role, you will support the design and execution of process development studies, analyze manufacturing data, and author technical documentation, including validation protocols and reports. Your experience 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 collaboration with analytical, production, quality, and project management teams, you will help ensure the successful and timely delivery of manufacturing and validation milestones.

Requirements

• Bachelor’s degree in Science or Engineering with a minimum of 7 years of relevant experience.
• Strong understanding of process design principles.
• Experience supporting drug product manufacturing processes, including process scale-up and optimization.
• Experience supporting sterile manufacturing operations (aseptic processing or isolator technology).
• Strong analytical skills, including data evaluation, statistical analysis, and process control interpretation.
• Ability to manage multiple priorities in a dynamic environment and perform under tight timelines.
• Excellent written and verbal communication skills, including technical writing.
• Proficient knowledge of CGMP.
• Ability to apply judgment when selecting methods and techniques to solve problems.
• Ability to work effectively across multiple departments and varying levels of experience.
• Demonstrated ability to communicate effectively with diverse individuals and groups.
• Demonstrated problem-solving skills and sound decision-making ability.
• Use of hearing, eye, and gown protection as required.

Nice To Haves

• Regulatory experience supporting pharmaceutical development or research programs.

Responsibilities

• Support process development activities and assist in the design and execution of studies for process development, optimization, scale-up, manufacturing records, and technology transfer.
• Support the design of studies to evaluate manufacturing process robustness and contribute to establishing baselines for process validation activities.
• Evaluate process data and perform analysis using scientific principles to support understanding of critical process parameters.
• Support the execution of experiments for the development and characterization of new manufacturing processes.
• Support process validation activities, including authoring protocols such as engineering runs and process performance qualifications.
• Analyze process data from clinical and commercial manufacturing batches to assess process performance and support batch release activities.
• Apply statistical and scientific analysis methods to evaluate manufacturing data and identify trends.
• Collaborate with analytical, production, quality, and project management teams to support the timely completion of project deliverables.
• Participate in meetings with internal stakeholders and clients to support technical discussions.
• Work with technical staff and leadership to support the evaluation of project requirements and scope.
• Contribute as an active team member and guide junior personnel as appropriate.
• Author and support technical documentation, including protocols, reports, deviations, gap analyses, and risk assessments.
• Support the development of manufacturing production records and protocols for qualification, technical transfer, and manufacturing activities.
• Write and revise Standard Operating Procedures (SOPs) and batch records.
• Apply CGMP and GDP requirements across all areas of work.
• Provide technical support for fill-finish manufacturing activities, including support of OOS/OOT investigations, process deviation assessments, and root cause analysis.
• Support process optimization activities and continuous improvement initiatives.
• Provide training support to production or laboratory staff on protocol requirements and processes.
• Work effectively across departments, including production, laboratory, engineering, and materials management.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees