Specialist Manufacturing (Biotechnology Industry) 3212778
Job Title: Specialist Manufacturing (Biotechnology Industry)
Job ID: 3212778
Location: Caguas, Puerto Rico (Opportunity open to residents of Puerto Rico)
Work Schedule: 100% Onsite | Monday to Friday | 8:00 AM – 5:00 PM
Duration: Approximately 7 months
Openings: 1
Summary
Our client in the biotechnology industry is seeking a Specialist in Manufacturing Operations to support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. This role requires minimal supervision and involves applying scientific, operational, and compliance expertise to support day-to-day manufacturing operations. The ideal candidate will also assist in troubleshooting, documentation management, and continuous process improvement.
Preferred Qualifications
- Experience handling documents in Veeva Vault (CDOCs) or similar document management systems
- Proficiency in change control processes and documentation
Key Responsibilities
Applied Process Expertise
- Initiate, revise, and approve manufacturing procedures ensuring alignment with current operations
- Serve as document owner and maintain up-to-date procedure documentation
- Evaluate and improve process performance through data analysis and floor observation
- Provide technical troubleshooting support
- Assist in developing training materials and support training delivery on technical or scientific topics
Process Monitoring
- Support the establishment of process monitoring parameters and control limits
- Collect process-monitoring data and assist in deviation assessments
- Contribute to timely execution of quarterly process monitoring reports
Non-Conformance and CAPA
- Ensure non-conformances are triaged and addressed within established timelines
- Author investigation reports and manage the execution of corrective actions
- Oversee the closure of non-conformances and CAPAs
- Monitor trends and provide communication of incident data
- Review and support root cause analysis investigations and trend assessments
Process Validation
- Assist in drafting process validation protocols and reports
- Support the execution of validation protocols
- Collect and analyze data to support process validation activities
Regulatory Compliance
- May participate in regulatory inspections and ensure compliance with relevant standards
New Product Introductions & Equipment Modifications
- Participate in NPI processes by evaluating documentation, materials, training, and equipment requirements
- Support project management for equipment or process modifications, including prioritization and implementation
Change Control
- Assist with change control processes, including supporting the manufacturing change owner on CCRB packages
Projects and Initiatives
- Contribute to the assessment and implementation of special projects or initiatives
Note: Additional responsibilities may be assigned as required.
Education & Experience Requirements
- Doctorate degree; OR
- Master’s degree with 3 years of experience in Manufacturing Operations; OR
- Bachelor’s degree with 5 years of experience in Manufacturing Operations; OR
- Associate degree with 10 years of experience; OR
- High School diploma / GED with 12 years of relevant experience
Core Competencies & Skills
- In-depth technical knowledge of bioprocessing unit operations
- Proficiency in GMP-compliant manufacturing environments
- Understanding of regulatory standards and agency interactions
- Strong cross-functional collaboration and communication abilities
- Excellent technical writing and organizational skills
- Effective presentation and documentation capabilities
- Familiarity with project management principles
- Basic understanding of control charting and statistical tools
Interested candidates who meet the above qualifications are encouraged to apply by submitting their updated resume through the job description link. We look forward to reviewing your application.