MS&T Engineer I

Responsibilities

• Author, revise, and maintain GMP documentation including Standard Operating Procedures (SOPs), Batch Records, Forms, Manufacturing Instructions, Training Materials, and On-the-Job Training (OJT) assessments.
• Support development of manufacturing records for inspection, assembly, labeling, serialization, and packaging operations.
• Ensure all documentation is accurate, compliant, easily understood, and aligned with company policies, client requirements, and regulatory expectations.
• Apply technical writing and human performance principles to improve document usability and right-first-time execution.
• Manage documentation projects and coordinate reviews, approvals, and implementation activities.
• Monitor documentation metrics and identify opportunities for continuous improvement.
• Support client product and process transfer activities from development through commercial manufacturing.
• Collaborate with client and site technical teams to gather, reconcile, and align process information required for successful technology transfer.
• Create and maintain manufacturing process flow diagrams, process maps, and technical transfer documentation for inspection and packaging operations.
• Generate engineering/experimental protocols to support new business.
• Work with Quality Engineering and Procurement to generate Production Order requests for new business materials.
• Support project timelines by tracking technical transfer deliverables and ensuring completion of assigned activities.
• Support process characterization, scale-up, process validation, and CPV activities.
• Aid in implementation of new products, packaging configurations, and manufacturing technologies.
• Participate in manufacturing readiness assessments and process implementation activities.
• Support technical risk assessments and process improvement initiatives.
• Review and analyze manufacturing and process data to identify trends, investigate issues, and support engineering reports.
• Monitor documentation and process performance metrics to identify opportunities for improvement and error reduction.
• Support process optimization initiatives.
• Evaluate existing processes and documentation systems and recommend improvements to enhance efficiency, compliance, and operational performance.
• Develop training materials and conduct classroom and on-the-job training sessions.
• Ensure personnel are adequately trained on new or revised procedures and manufacturing processes.
• Serve as a technical resource for manufacturing and support teams regarding documentation and process-related questions.
• Support knowledge transfer activities associated with new product introductions and process improvements.

Requirements

• SITE Bachelor’s Degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline preferred (Associate’s Degree with relevant experience considered).
• 1+ years of pharmaceutical, biotechnology, medical device, or related regulated manufacturing experience.
• Knowledge of GMP regulations and quality systems requirements.
• Strong technical writing and document development skills.
• Experience interpreting manufacturing processes and translating them into executable procedures.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Visio) and Adobe Acrobat.
• Strong analytical, organizational, and project management skills.
• Excellent verbal and written communication skills.
• Ability to collaborate effectively with cross-functional teams and clients.

Qualifications

• Familiarity with visual inspection, assembly, labeling, serialization, and packaging operations preferred.
• Experience supporting technology transfer activities.
• Experience in sterile injectable manufacturing.
• Experience with process mapping, data trending, and continuous improvement methodologies.
• Familiarity with sterile injectables manufacturing systems and electronic documentation platforms.

Skills

• Technical Writing
• Document Development
• Manufacturing Documentation
• Process Transfer
• Quality Systems
• Project Management
• Training
• Continuous Improvement

Benefits

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