Manufacturing Specialist

Title: Specialist Manufacturing (3602239)

Location: Juncos, Puerto Rico

(Open to Puerto Rico Residents Only)

Number of Positions: 5 Openings

Schedule

• Onsite position
• Administrative Shift
• Overtime required based on business needs

Contract Duration: 5-Month Contract

Position Summary

Our client is seeking a Specialist Manufacturing professional to support manufacturing and quality operations within a regulated pharmaceutical environment. Under minimal supervision, the selected candidate will support the execution of manufacturing and quality systems, including non-conformances, process validation, training, procedures, change controls, and new product introductions.

The ideal candidate will apply scientific, operational, and process expertise while supporting compliance initiatives, troubleshooting activities, and continuous improvement efforts within manufacturing operations.

Preferred Qualifications

• Minimum of 4 years of Manufacturing Operations experience
• Experience with:
• Deviations documentation
• Change Control Management
• GMP manufacturing environments
• Availability to work the Administrative Shift and overtime based on business needs

Essential Functions

Applied Process Expertise

• Initiate, revise, review, and approve manufacturing procedures while ensuring documents reflect current operations
• Serve as document owner for manufacturing procedures
• Assess process performance through floor observations and performance data analysis
• Identify, evaluate, and implement process improvement opportunities
• Provide technical troubleshooting support
• Assist in the development of training materials and support technical or scientific training activities

Process Monitoring

• Support the establishment of process monitoring parameters and control limits
• Collect and analyze process monitoring data
• Support deviation assessments and investigations
• Assist with the timely execution of quarterly process monitoring reports

Non-Conformance and CAPA Management

• Ensure non-conformances are triaged within established timelines
• Author investigation reports related to manufacturing events and deviations
• Execute corrective and preventive actions (CAPAs)
• Manage NC/CAPA closure activities within established goals
• Monitor, trend, and communicate manufacturing incidents
• Review equipment and system Root Cause Analysis investigations
• Support trend analysis evaluations

Process Validation

• Assist in the generation of process validation protocols and reports
• Support process validation execution activities
• Collect and analyze process validation data

Regulatory Support

• Participate in regulatory inspections and audit readiness activities
• Support New Product Introductions (NPI)
• Participate in process and equipment modification projects

NPI and Modification Activities

• Assess documentation, materials, training, and equipment modification requirements
• Support implementation and project management activities for process or equipment modifications
• Prioritize and justify project-related activities

Change Control

• Support manufacturing change owners with CCRB packages impacting manufacturing processes

Projects and Initiatives

• Participate in special projects, continuous improvement initiatives, and operational assessments
• Perform additional duties as assigned

Education Requirements

Candidates must meet one of the following education and experience combinations:

• Doctorate Degree
• OR
• Master’s Degree + 2 years of Manufacturing Operations experience
• OR
• Bachelor’s Degree + 4 years of Manufacturing Operations experience
• OR
• Associate Degree + 8 years of Manufacturing Operations experience
• OR
• High School Diploma/GED + 10 years of Manufacturing Operations experience

Competencies and Skills

• Strong technical understanding of bioprocessing unit operations
• Experience performing GMP production operations
• Knowledge of regulatory compliance and agency interactions
• Ability to participate in and support cross-functional teams
• Strong communication and collaboration skills across manufacturing, process development, quality, and management teams
• Excellent organizational, technical writing, and presentation skills
• Basic project management skills
• Basic knowledge of control charting and data trending