Principal Engineer

Role Summary

Principal Engineer role focused on providing process support for manufacturing purification processes, investigating and troubleshooting technical issues, and assisting with yield and process improvements, validation activities, and compliance within the Social Circle purification manufacturing departments.

Responsibilities

• Act as protein purification expert to provide technical support for complex manufacturing scale investigations and process improvement projects; devise new approaches and incorporate new methods and technologies.
• Serve as subject matter expert in protein purification and protein separation techniques (filtration, centrifugation, chromatography).
• Evaluate and prepare complex product impact assessments for process exceptions.
• Support commercial manufacturing operations to meet fulfillment targets; complete CAPA tasks to ensure on-time release of lots, product impact assessments, corrective and preventive actions, and root cause investigations as needed.
• Work independently to initiate and conduct studies and improvement projects for product quality, process robustness, yield, and cycle time.
• Provide training and supervision to junior team members; advise colleagues on unique problems.
• Maintain GxP knowledge and provide insights to facilitate efficient product registration and interpretation of regulations.
• Adhere to quality systems and applicable procedures; knowledge of USP, ICH, and regional compendia to facilitate compliance.
• Present information to internal and external auditors.
• Collaborate with manufacturing and global subject matter experts to identify process improvement opportunities and to execute improvement projects, including validation support and submission writing.
• Possibly conduct small-scale experiments and promote metrics such as yields and capacity.
• Author and execute process validation protocols and final reports; coordinate and support training and execution of validation activities; interpret results relative to protocol requirements.
• Promote DMAIC problem-solving approach and analyze scientific and statistical data to draw conclusions.

Qualifications

• Requires a bachelor's degree in science, engineering, or related field with 15+ years of related experience; advanced degree (MS, PhD) preferred.
• Knowledge of FDA-regulated manufacturing environments; GMPs, FDA guidelines, and process validation.
• Practical and theoretical knowledge of purification of plasma proteins and biochemistry.
• Ability to solve routine and complex technical problems; strong communication skills; ability to interact with cross-functional teams and management.
• Ability to prioritize multiple tasks and manage multiple projects; self-motivated with good interpersonal skills.
• Experience with DOE, six sigma, lean manufacturing a plus; proficient computer skills (MS Office); familiarity with Minitab or other statistical software preferred.
• Strong presentation, verbal, and written communication; ability to lead teams and collaborate effectively.
• Ability to work in a fast-paced, cross-functional environment; self-driven with minimal supervision.

Skills

• Protein purification techniques and protein separation methods (filtration, centrifugation, chromatography).
• Process validation, quality systems, CAPA, root cause investigations, and risk assessment.
• Statistical analysis and data interpretation; DMAIC methodology; DOE knowledge.
• Project management, cross-functional leadership, and training/mentoring abilities.
• Regulatory knowledge (GxP, USP, ICH) and compliance readiness for product registration.

Education

• Bachelor‚Äôs degree in science, engineering, or related field; MS/PhD preferred.

Additional Requirements

• Ability to work shifts including nights, weekends, and holidays on an infrequent basis; ability to work in a clean room environment; ability to wear PPE as required.
• Ability to travel infrequently.