Sr. Investigator Specialist

Position Summary:
Responsible for supporting manufacturing operations through technical investigations, process monitoring, documentation review, and continuous improvement initiatives within a regulated biopharmaceutical environment. The role requires collaboration across Manufacturing, Process Development, Quality, and other cross-functional teams to ensure compliance, product quality, and operational excellence.

Key Responsibilities:

• Support manufacturing operations and bio-processing unit operations activities.
• Conduct and support investigations, deviations, and root cause analyses.
• Monitor manufacturing processes and identify opportunities for continuous improvement.
• Collaborate with cross-functional teams including Manufacturing, Process Development, Quality, and Engineering.
• Prepare, review, and maintain technical documentation in compliance with Good Documentation Practices (GDP).
• Analyze process data and trends using available systems and monitoring tools.
• Support Lean Manufacturing and operational excellence initiatives.
• Prepare technical reports, presentations, and documentation for management review.
• Ensure compliance with applicable regulations, procedures, and quality standards.

Required Qualifications:

• Bachelor's Degree in Engineering, Biotechnology, Life Sciences, Microbiology, Chemistry, or a related scientific discipline.
• Experience in a regulated pharmaceutical, biotechnology, or medical device manufacturing environment.
• Strong written and verbal communication skills in English and Spanish.
• Proficiency in technical writing and presentation development.
• Ability to work effectively in a team-based environment.
• Excellent interpersonal and collaboration skills.
• Ability to work independently with minimal supervision.
• Availability to work under high workload conditions and extended hours when required.

Preferred Qualifications:

• Experience in bio-processing unit operations.
• Knowledge of Root Cause Analysis (RCA) methodologies, including Fishbone, Six Boxes, 5 Why's, and Kepner-Tregoe.
• Familiarity with Lean Manufacturing practices and continuous improvement methodologies.
• Ability to communicate and collaborate effectively with technical and management personnel across Manufacturing, Process Development, and Quality organizations.
• Proficiency in Good Documentation Practices (GDP) within a regulated environment.
• Experience with systems and tools such as TrackWise, Veeva, MES, SmartSheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms.
• Strong analytical and problem-solving skills.
• Excellent organizational and time management abilities.

Cost/Risk Consideration:

Candidates without direct experience in bio-processing operations, RCA methodologies, or the listed manufacturing systems and platforms may require additional onboarding and training. Any associated training costs, timeline impacts, or productivity ramp-up considerations should be evaluated and reflected in the project planning and pricing model, as applicable.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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