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Title: Specialist Manufacturing ProQN561 – Biotechnology Industry

Location: Juncos, Puerto Rico (Only for Puerto Rico residents)

Openings: 6 Positions

Schedule: Administrative Shift (8 hours)

Overtime: Availability to work overtime based on business needs

Contract: 4 months

Position Summary

Our client is seeking Specialist Manufacturing professionals to support manufacturing operations within a regulated biotechnology environment. This role is responsible for supporting manufacturing and quality systems, including deviations, non-conformances, CAPA, process validation, change control, training, and New Product Introductions (NPI). The selected candidate will apply technical expertise, analytical thinking, and troubleshooting skills to ensure GMP compliance, improve manufacturing performance, and support continuous improvement initiatives.

Key Responsibilities

• Support manufacturing operations by troubleshooting process-related issues and identifying opportunities for continuous improvement.
• Initiate, revise, review, and maintain manufacturing procedures while serving as a document owner when required.
• Monitor manufacturing process performance through floor observations and data analysis.
• Manage the complete lifecycle of deviations, including deviation assessments, investigations, root cause analysis, CAPA implementation, and timely closure using TrackWise.
• Author investigation reports, support non-conformance management, and monitor incident trends.
• Assist with process validation activities, including protocol development, execution, data collection, and reporting.
• Participate in regulatory inspections and maintain compliance with GMP requirements.
• Support New Product Introductions (NPI), process improvements, equipment modifications, and change control activities.
• Collaborate with Manufacturing, Process Development, Engineering, and Quality teams to implement process improvements and support special projects.
• Assist in developing technical training materials and providing process-related training.

Preferred Qualifications

• Bachelor's degree in Engineering is highly preferred.
• Biotechnology and pharmaceutical manufacturing experience.
• Hands-on experience managing deviations and performing deviation assessments.
• Experience managing the complete lifecycle of deviations from initiation through closure.
• Experience using TrackWise.
• Knowledge of GMP manufacturing operations and regulatory requirements.
• Experience with CAPA, investigations, process validation, change control, and Root Cause Analysis (RCA).
• Strong analytical, troubleshooting, technical writing, and organizational skills.
• Ability to collaborate effectively with cross-functional teams.
• Basic project management and process monitoring knowledge.

Minimum Education & Experience

Candidates must meet one of the following requirements:

• Doctorate Degree, or
• Master's Degree with 2+ years of Manufacturing Operations experience, or
• Bachelor's Degree with 4+ years of Manufacturing Operations experience, or
• Associate's Degree with 8+ years of Manufacturing Operations experience, or
• High School Diploma/GED with 10+ years of Manufacturing Operations experience.