Our Work MattersAt Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will MakeThe MS&T Engineer I supports technical transfer, process implementation, and manufacturing support activities for visual inspection, assembly, labeling, serialization, and packaging operations for clinical and commercial sterile injectable products.
This role is responsible for developing manufacturing documentation, supporting process transfers, analyzing manufacturing data, creating process flow diagrams, ordering materials to support new processes, and driving continuous improvement initiatives. The position works cross-functionally with clients and internal stakeholders to ensure manufacturing processes are accurately translated into production-ready instructions, executed in compliance with GMP requirements, and supported through training and technical expertise.
Responsibilities- Documentation Development & Management
- 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.
- Technical Transfer & Process Support
- 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.
- Assist 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.
- Process Analysis & Continuous Improvement
- 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.
- Process Analysis & Continuous Improvement
- 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.
- Training & Knowledge Transfer
- 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.
Basic QualificationsSITE- 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.
Preferred 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.
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Notice for California Employees and Applicants before applying.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees-regardless of format-without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Equal Opportunity Employer: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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