Specialist Manufacturing 3380645
Job Title: Specialist, Manufacturing (Biotechnology Industry)
Location: East Region, Puerto Rico (Hybrid/Remote – Only open to Puerto Rico residents)
Duration: Approximately 1 Year
Open Positions: 2
Summary
Our client is seeking two Manufacturing Specialists to support manufacturing and quality systems in the biotechnology industry. This hybrid/remote role requires candidates to be based in Puerto Rico. The position involves supporting non-conformances, process validation, training, documentation, and new product introductions with minimal supervision. Candidates must apply scientific and operational expertise, compliance knowledge, and strong analytical and troubleshooting skills to ensure consistent manufacturing support and process optimization.
Key Responsibilities
Process Expertise & Documentation
- Initiate, revise, and approve manufacturing procedures; serve as document owner.
- Ensure procedures are aligned with current operations.
- Assess manufacturing performance through floor observation and performance data review.
- Identify, plan, and implement process improvement solutions.
- Provide technical troubleshooting support.
- Assist in creating and delivering process-related training materials.
Process Monitoring
- Support establishment of process monitoring parameters and control limits.
- Collect and analyze process monitoring data.
- Support timely completion of quarterly process monitoring reports.
Non-Conformance Management & CAPA
- Triage non-conformances and ensure timely investigation initiation.
- Author investigation reports and manage the execution of corrective actions.
- Ensure timely closure of NC/CAPA records.
- Monitor and communicate incident trends.
- Review root cause analysis for equipment/system issues and support trending evaluations.
Process Validation
- Assist in drafting and executing process validation protocols and reports.
- Support data collection and analysis for validation activities.
Regulatory Support
- Participate in regulatory inspections and support readiness activities as needed.
New Product Introductions & Equipment Modifications
- Participate in NPI efforts by assessing documentation, materials, training, and equipment needs.
- Support implementation and project management for process or equipment changes.
Change Control
- Assist with change control records impacting manufacturing processes.
Projects and Initiatives
- Contribute to the assessment and execution of special projects or initiatives.
- Other duties may be assigned.
Education Requirements
- Doctorate; OR
- Master’s degree with 2+ years of manufacturing operations experience; OR
- Bachelor’s degree with 4+ years of experience; OR
- Associate degree with 8+ years of experience; OR
- High school diploma/GED with 10+ years of experience.
Preferred Qualifications & Skills
- Experience supporting drug substance processes and data-driven process monitoring.
- Proficiency with systems such as SAP, TrackWise, electronic batch records, and document management systems.
- Strong knowledge of GMP manufacturing operations and regulatory compliance.
- Technical understanding of bioprocessing unit operations.
- Ability to work in and help lead cross-functional teams.
- Strong organizational, technical writing, and communication skills.
- Basic project management and control charting knowledge.