Manufacturing Specialist- PRQN 787

Frey Consulting Group; Juncos (PR); Hybrid; USD 42,000 - 64,000; Full time

Job summary

Frey Consulting Group is engaged to find a Manufacturing Specialist for our client in Puerto Rico. The role requires supporting manufacturing and quality systems with minimal supervision, covering non-conformances, CAPA, process validation, NPI, and manufacturing procedures.

The candidate may serve as the Process Owner for manufacturing support systems and work on process ownership responsibilities for complex systems.

Qualifications

• Requires strong knowledge of GMP manufacturing operations.
• Experience supporting or performing GMP manufacturing operations.
• Knowledge of regulatory requirements and interaction with regulatory functions.
• Ability to lead cross-functional teams and manage multiple priorities.
• Strong analytical and troubleshooting skills.

Responsibilities

• Initiate, revise, and approve manufacturing procedures with accurate documentation.
• Serve as Document Owner for manufacturing procedures.
• Monitor process performance through observation and data review.
• Identify process improvements and implement solutions.
• Provide troubleshooting support for manufacturing processes.
• Assist with training materials development and delivery.
• Support training on scientific and technical aspects of manufacturing.

Skills

Analytical thinking

Troubleshooting

Technical writing

Communication

Independent work

Education

Master's degree + 2 years experience

Bachelor's degree + 4 years experience

Associate's degree + 8 years experience

High School Diploma/GED + 10 years experience

Bioprocessing knowledge

GMP manufacturing experience

Regulatory requirements knowledge

Cross-functional leadership

Tools

TrackWise

SAP

Job description

Tittle: Manufacturing Specialist – PRQN-787

Work Schedule: Hybrid – Administrative Shift

Availability: Must be available to work different shifts and/or weekends as business needs require

Contract Duration: 5 months

Position Available: 1

This opportunity is available only to direct individual candidates. Submissions from third-party contractors, staffing agencies, vendors, or Corp-to-Corp (C2C) arrangements will not be considered.

Position Summary

Our client is seeking a Manufacturing Specialist to support manufacturing and quality systems with minimal supervision. The individual will provide technical and operational support in areas including non-conformances, CAPA, process validation, manufacturing procedures, training, process monitoring, and New Product Introductions (NPI).

The role requires strong process, operational, and scientific knowledge, along with analytical, troubleshooting, technical writing, and problem-solving skills. The selected candidate may serve as the primary Process Owner for manufacturing process support systems and assist with process ownership responsibilities for more complex systems.

Key Responsibilities

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures, ensuring documentation accurately reflects current operations.
• Serve as a Document Owner for applicable manufacturing procedures.
• Assess process performance through direct observation of manufacturing floor operations and review of performance data.
• Identify process improvement opportunities and evaluate, plan, and implement appropriate solutions.
• Provide technical troubleshooting support for manufacturing processes.
• Assist with the development of training materials.
• Support or provide training on the scientific and technical aspects of manufacturing processes.

Process Monitoring

• Support the establishment of process monitoring parameters and control limits.
• Collect and analyze process monitoring data.
• Support the assessment and evaluation of process deviations.
• Support the timely preparation and execution of quarterly process monitoring reports.

Non-Conformances and CAPA

• Ensure non-conformances are triaged within established timelines and quality goals.
• Author investigation reports and ensure appropriate documentation.
• Execute assigned corrective actions.
• Manage Non-Conformance/CAPA activities through timely closure.
• Monitor and communicate incident and quality trends.
• Review equipment and system Root Cause Analysis (RCA) investigations.
• Support trend evaluations and identification of recurring issues.

Process Validation

• Assist with the development of process validation protocols and reports.
• Support the execution of process validation activities.
• Assist with the collection, review, and analysis of process validation data.

Regulatory, NPI, and Process/Equipment Modifications

• Participate in regulatory inspections, New Product Introductions (NPI), and process or equipment modification activities, as needed.
• Participate in NPI activities by assessing requirements related to:
• Documentation
• Materials
• Training
• Equipment modifications
• Assess, prioritize, and justify process or equipment modification initiatives.
• Provide implementation and project management support for process and equipment modification projects.

Change Control

• Assist Manufacturing Change Owners with CCRB (Change Control Review Board) packages that impact manufacturing processes.
• Support the preparation, review, and progression of change control documentation.

Projects and Initiatives

• Participate in the assessment, planning, and implementation of special projects and manufacturing initiatives.
• Collaborate with cross-functional teams to support business and operational objectives.

Additional responsibilities may be assigned based on business needs.

Education & Experience

Candidates must meet one of the following requirements:

• Master's degree plus 2 years of Manufacturing Operations experience; or
• Bachelor's degree plus 4 years of Manufacturing Operations experience; or
• Associate's degree plus 8 years of Manufacturing Operations experience; or
• High School Diploma/GED plus 10 years of Manufacturing Operations experience.
• Strong technical understanding of bioprocessing unit operations.
• Experience supporting or performing GMP manufacturing operations.
• Knowledge of applicable regulatory requirements and experience interacting with regulatory functions.
• Ability to participate in and support the leadership of cross-functional teams.
• Strong communication and collaboration skills when working with Manufacturing, Process Development, Quality, technical teams, and management.
• Strong organizational, technical writing, and presentation skills.
• Basic project management knowledge and experience.
• Basic understanding of control charting and process monitoring.
• Strong analytical and troubleshooting skills.
• Ability to work independently with minimal supervision.

Preferred Qualifications

The ideal candidate will bring additional experience that supports the role's responsibility as an External Supply Quality Record Owner.

Preferred qualifications include:

• Experience managing and executing supplier-related Change Control quality records with minimal supervision.
• Experience serving as a Quality Record Owner or similar role.
• Strong knowledge of Change Control processes and quality systems.
• Ability to lead cross-functional meetings and drive Change Control records toward timely completion and closure.
• Strong critical-thinking skills with the ability to evaluate and assess supplier-related quality records.
• Hands-on experience with TrackWise and SAP.
• Experience working with external suppliers and cross-functional stakeholders.
• Strong communication, collaboration, organization, and follow-through skills.
• Demonstrated ability to manage multiple priorities and drive results across different functional groups.
• Experience supporting quality investigations, CAPA, deviations, or other quality-system records is highly desirable.