Title: Manufacturing Specialist (3606704)
Location: Puerto Rico
Work Schedule: Hybrid – Administrative Shift
Eligibility: Open to Puerto Rico Residents
Positions Available: 1
Contract Duration: 5 Months
Position Summary
Our client is seeking a Manufacturing Specialist to support manufacturing and quality operations within a regulated pharmaceutical manufacturing environment. This role requires a strong technical background in manufacturing processes, deviation investigations, process validation, and quality systems compliance.
The selected candidate will support manufacturing operations with minimal supervision by applying scientific, operational, and compliance expertise to improve process performance, support troubleshooting activities, and ensure adherence to cGMP regulations and internal quality standards.
The ideal candidate will possess strong analytical, technical writing, problem-solving, and cross-functional collaboration skills, along with experience supporting bioprocess manufacturing operations and quality systems.
Key Responsibilities
Manufacturing and Process Support
- Support manufacturing operations by providing technical and operational expertise in regulated GMP environments.
- Serve as a process support resource and assist with process ownership activities for manufacturing systems.
- Provide floor support and troubleshooting assistance during manufacturing operations and commercial campaigns.
- Assess process performance through floor observations, process monitoring, and performance data analysis.
- Evaluate and implement process improvement opportunities to optimize operational efficiency and compliance.
Change Control and Investigations
- Own and manage change controls related to manufacturing process changes.
- Support deviation investigations throughout the full lifecycle, including:
- Root Cause Analysis (RCA)
- Corrective and Preventive Actions (CAPA)
- Investigation report authoring
- Regulatory inspection support
- Perform and support risk assessments and microbial assessment evaluations.
- Review equipment and system Root Cause Analysis investigations and support trend evaluations.
- Monitor, communicate, and trend manufacturing incidents and quality events.
Documentation and Compliance
- Initiate, revise, review, and approve manufacturing procedures while ensuring alignment with current operations.
- Serve as a document owner for manufacturing procedures and controlled documentation.
- Ensure compliance with Good Documentation Practices (GDP) and cGMP requirements.
- Assist with Master Batch Record (MBR) creation and revision activities.
- Support closure of Non-Conformances (NCs) and CAPAs within established timelines.
Process Monitoring and Validation
- Support establishment of process monitoring parameters and control limits.
- Collect and analyze process monitoring data and support deviation assessments.
- Assist with the preparation and execution of quarterly process monitoring reports.
- Support process validation activities, including:
- Protocol generation
- Validation execution
- Data collection and analysis
- Report support
- Design, coordinate, and support functional testing, water testing, and process challenge runs during major changes and campaign readiness activities.
- Generate technical protocols and supporting documentation as required.
Training and Cross-Functional Support
- Assist in developing training materials and provide technical or scientific training support when needed.
- Collaborate effectively with Manufacturing, Quality, Engineering, Process Development, and Technical Operations teams.
- Support New Product Introduction (NPI) activities by assessing requirements for:
- Documentation
- Materials
- Equipment modifications
- Training needs
Projects and Continuous Improvement
- Support process, automation, and equipment modification projects.
- Participate in special projects, continuous improvement initiatives, and implementation activities.
- Provide project coordination and implementation support for manufacturing process changes and equipment upgrades.
Preferred Qualifications
Preferred educational background in:
- Life Sciences
- Engineering
- Related Scientific Discipline
Technical Experience
- Experience in bioprocessing unit operations within pharmaceutical or biotechnology manufacturing environments.
- Knowledge of Root Cause Analysis methodologies, including:
- Fishbone
- 5 Why’s
- Kepner-Tregoe
- Six Boxes
- Familiarity with Lean Manufacturing principles and continuous improvement methodologies.
- Experience supporting GMP manufacturing operations and regulated quality systems.
- Understanding of process monitoring, trend analysis, and statistical evaluation tools.
- Knowledge of process validation and manufacturing support activities.
Systems Knowledge
Experience with the following systems is preferred:
- TrackWise
- Spotfire
- CDOCS
- Process Monitoring Platforms
Additional Skills
- Strong technical writing and presentation skills.
- Excellent verbal and written communication skills in English and Spanish.
- Ability to collaborate effectively with technical and management teams.
- Strong organizational, analytical, and troubleshooting abilities.
- Basic project management skills.
- Knowledge of control charting and process monitoring tools.
Core Functional Areas
Applied Process Expertise
- Manufacturing procedure management
- Process troubleshooting
- Process improvement implementation
- Technical training support
Process Monitoring
- Monitoring parameter establishment
- Trend analysis and deviation support
- Quarterly process monitoring reporting
Non-Conformance and CAPA Management
- Investigation report authoring
- CAPA execution and tracking
- Incident trend monitoring
- Root Cause Analysis support
Process Validation
- Validation protocol generation
- Validation execution support
- Data collection and analysis
Regulatory and Compliance Support
- Regulatory inspection participation
- NPI support activities
- Equipment and process modification assessments
Change Control Management
- CCRB package support
- Manufacturing process change coordination
Projects and Initiatives
- Special project implementation
- Continuous improvement support
- Cross-functional collaboration
Minimum Education and Experience Requirements
Candidates must meet one of the following combinations:
- 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 Degree with 8+ years of Manufacturing Operations experience OR
- High School Diploma/GED with 10+ years of Manufacturing Operations experience
Competencies and Skills
- Strong technical understanding of bioprocess manufacturing operations
- Experience supporting GMP production environments
- Knowledge of regulatory requirements and quality systems
- Ability to participate in and support cross-functional teams
- Strong analytical and troubleshooting skills
- Excellent technical writing and communication abilities
- Organizational and project coordination skills
- Ability to work independently with minimal supervision
- Strong collaboration skills across Manufacturing, Quality, and Process Development teams