Manufacturing Specialist ProQN632

Frey Consulting Group; Juncos (PR); On-site; USD 60,000 - 95,000; Full time

Job summary

Frey Consulting Group in the United States is seeking a Manufacturing Specialist to work independently with minimal supervision and provide technical and operational support to manufacturing activities and quality systems.

The ideal candidate will apply manufacturing, scientific, and process expertise to support areas such as non-conformances, CAPA, process validation, procedures, training, change control owner, and New Product Introductions (NPI).

Qualifications

• Doctorate or equivalent in manufacturing operations or related field.
• Master’s degree with 2+ years manufacturing ops experience.
• Bachelor’s degree with 4+ years manufacturing ops experience.
• Associate degree with 8+ years manufacturing ops experience.
• High school diploma/GED with 10+ years manufacturing ops experience.
• Strong technical understanding of bioprocessing unit operations.
• Hands-on GMP manufacturing operations experience.
• Knowledge of regulatory requirements and regulatory activities.
• Ability to participate in cross-functional teams.
• Strong communication and technical writing skills.
• Basic project management knowledge and experience.
• Basic understanding of control charting and process monitoring.
• Strong analytical, troubleshooting, and problem-solving skills.
• Ability to work independently while managing multiple priorities in a regulated environment.

Responsibilities

• Initiate, revise, and approve manufacturing procedures with accurate documentation.
• Serve as a document owner and ensure procedures meet cGMP/regulatory requirements.
• Evaluate process performance via floor observations and data reviews.
• Identify process improvement opportunities and support solutions.
• Provide technical troubleshooting for manufacturing operations.
• Develop training materials and deliver training on manufacturing processes.
• Identify and address process risks to protect product quality and safety.
• Maintain Electronic Batch Records aligned with current processes and training.
• Assist with process monitoring parameters and control limits.
• Collect and analyze monitoring data and support deviation assessments.
• Support non-conformance and CAPA activities, including investigations.
• Review RCA investigations and support trend evaluations.
• Assist with process validation activities and data analysis.
• Participate in regulatory inspections and NPI activities.
• Support documentation, material, and equipment requirements for changes.
• Assess and support process/equipment modification projects and basic PM.
• Support Change Control activities as a change control owner.
• Participate in non-commercial production runs and special projects.

Skills

GMP manufacturing

Document control

Process monitoring

CAPA

Cross-functional collaboration

Technical writing

Problem solving

Education

Doctorate in relevant discipline

Master’s degree + 2 years Manufacturing Operations experience

Bachelor’s degree + 4 years Manufacturing Operations experience

Associate degree + 8 years Manufacturing Operations experience

High school diploma/GED + 10 years Manufacturing Operations experience

Job description

Work Schedule: Administrative Shift | 8:00 AM – 5:00 PM

Schedule Flexibility: Overtime may be required based on business needs.

Positions Available: 1

Contract Duration: 6 months

Position Overview

Our client is seeking a Manufacturing Specialist who can work independently with minimal supervision and provide technical and operational support to manufacturing activities and quality systems.

The ideal candidate will apply manufacturing, scientific, and process expertise to support areas such as non-conformances, CAPA, process validation, procedures, training, change control owner, and New Product Introductions (NPI). The role may also serve as a primary process owner for designated production support systems and assist with more complex process ownership activities.

Key Responsibilities

• Initiate, revise, and approve manufacturing procedures, ensuring documentation accurately reflects current operations.
• Serve as a document owner and ensure procedures comply with cGMP and applicable regulatory requirements.
• Evaluate process performance through floor observations and review of manufacturing data.
• Identify process improvement opportunities and support the planning and implementation of solutions.
• Provide technical troubleshooting support to manufacturing operations.
• Develop training materials and support training on technical and scientific aspects of manufacturing processes.
• Ensure process risks are identified, assessed, and addressed to protect product safety, purity, quality, and efficiency.
• Ensure Electronic Batch Records remain aligned with current manufacturing processes and support related training activities.
• Establish and support process monitoring parameters and control limits.
• Collect and analyze process-monitoring data and support deviation assessments and quarterly process monitoring reports.
• Support non-conformance and CAPA activities, including triage, investigation reports, corrective actions, closure, and trend monitoring.
• Review equipment and system Root Cause Analysis investigations and support related trend evaluations.
• Assist with the generation, execution, and reporting of process validation activities, including protocol development and data analysis.
• Participate in regulatory inspections, New Product Introductions, process modifications, and equipment modification projects.
• Support NPI activities by assessing documentation, material, training, and equipment requirements.
• Assess, prioritize, and support process or equipment modification projects, including implementation and basic project management activities.
• Support Change Control activities as a change control owner, and assist manufacturing change owners with CCRB packages affecting manufacturing processes.
• Participate in non-commercial production runs to support process data collection and analysis.
• Participate in special projects and department initiatives as assigned.
• Collaborate effectively with Manufacturing, Process Development, Quality, technical teams, and management.

Education & Experience

Candidates must meet one of the following requirements:

• Doctorate in a relevant discipline; 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.
• Strong technical understanding of bioprocessing unit operations.
• Hands-on experience supporting GMP manufacturing operations.
• Working knowledge of regulatory requirements and experience participating in regulatory activities.
• Ability to participate in and support cross-functional teams.
• Strong communication and collaboration skills when working with manufacturing, process development, quality, technical, and management teams.
• Strong organizational, technical writing, and presentation skills.
• Basic project management knowledge and experience.
• Basic understanding of control charting and process monitoring.
• Strong analytical, troubleshooting, and problem-solving skills.
• Ability to work independently while managing multiple priorities in a regulated manufacturing environment.

Additional responsibilities may be assigned based on business needs.