Manufacturing Specialist
Job Title: Specialist – Manufacturing (Background in Chemistry)
Location: Juncos, PR (Open to Puerto Rico Residents)
Work Schedule: 100% Onsite – Administrative Shift
Duration: Approximately 6 Months
Contracted by: ProQuality Network on behalf of our Biotechnology Client
Summary
Under minimal supervision, the Specialist – Manufacturing will support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. This role requires applying process knowledge, operational and scientific expertise, basic compliance principles, and strong analytical and troubleshooting skills to support manufacturing operations.
The selected candidate may act as the primary production process owner for certain process support systems and assist in more complex process systems.
Preferred Background:
- Educational or professional background in Chemistry
- Knowledge and hands-on experience in analytical lab processes, including:
- Assay development, validation, and monitoring
- Analytical methods (e.g., pH, conductivity, endotoxin testing)
- Sample testing and standards preparation
- Compendial and non-compendial test methods
- Reagent and solution preparation
- Sample management and equipment maintenance
Key Responsibilities
Applied Process Expertise
- Initiate, revise, and approve manufacturing procedures; serve as document owner
- Ensure procedures reflect current operations
- Assess process performance through floor observation and data review
- Identify and implement solutions for process improvement
- Provide troubleshooting and technical support
- Develop training materials and assist with technical training delivery
Process Monitoring
- Support process monitoring parameter and control limit establishment
- Collect and assess process monitoring data
- Assist with the timely execution of quarterly monitoring reports
Non-Conformance and CAPA
- Triage non-conformances within established timelines
- Author investigation reports and execute corrective actions
- Manage non-conformance (NC) and CAPA closures within defined goals
- Monitor and communicate incident trends
- Support Root Cause Analysis and trend evaluation
Process Validation
- Assist with generating and executing validation protocols and reports
- Collect and analyze process validation data
Regulatory Support
- Participate in regulatory inspections as needed
New Product Introductions & Equipment Modifications
- Participate in New Product Introduction (NPI) assessments for documentation, materials, training, and equipment needs
- Support implementation and project management of process/equipment modifications
Change Control
- Assist change owners in preparing CCRB packages related to manufacturing processes
Projects and Initiatives
- Contribute to the evaluation and execution of special projects and initiatives
Additional responsibilities may be assigned based on business needs.
Education / Experience Requirements
- Doctorate degree; OR
- Master’s degree and 3 years of experience in Manufacturing Operations; OR
- Bachelor’s degree and 5 years of experience; OR
- Associate’s degree and 10 years of experience; OR
- High school diploma / GED and 12 years of experience in Manufacturing Operations
Core Competencies / Skills
- Strong technical understanding of bioprocessing unit operations
- Skilled in GMP-compliant production operations
- Knowledge of regulatory guidelines and practices
- Experience participating in cross-functional teams
- Effective communication and collaboration skills
- Strong organizational and technical writing abilities
- Basic project management and control charting knowledge
- Comfortable delivering technical presentations
We invite qualified candidates to apply through the job description link to be considered for this exciting opportunity with our biotechnology client in collaboration with ProQuality Network.