Specialist Manufacturing 3455985

ProQuality Network; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

ProQuality Network is seeking a Manufacturing Specialist to support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. The role emphasizes GMP compliance, process ownership on selected platforms, and collaboration across operations, quality, and maintenance.

The ideal candidate will apply scientific and analytical skills to drive process improvements, ensure regulatory compliance, and serve as a primary process

Qualifications

• Doctorate or advanced degree in Engineering, Life Sciences, Biotechnology, Chemistry, or related field.
• Experience in regulated manufacturing environments (pharma/biotech/medical device).
• Familiarity with automation, process equipment, and Lean Six Sigma/Kaizen/RCAs.
• Ability to troubleshoot, implement CAPAs, and drive process improvements.
• Cross-functional collaboration with operations, quality, and maintenance teams.
• Strong GMP knowledge and regulatory documentation practices.
• Excellent communication and attention to detail.

Responsibilities

• Initiate, revise, and approve manufacturing procedures reflecting current operations.
• Serve as document owner ensuring procedural compliance across production.
• Assess process performance and implement efficiency/quality improvements.
• Provide troubleshooting support for manufacturing issues.
• Assist in generating training materials on technical manufacturing topics.
• Support process monitoring parameters and deviation assessments.
• Contribute to quarterly monitoring reports and CAPA management.
• Participate in regulatory inspections and NPIs.

Skills

Bioprocessing

GMP familiarity

Regulatory knowledge

Cross-functional leadership

Communication skills

Documentation

Technical writing

Project management

Data analysis

Control charts

Education

Doctorate Degree

Master’s Degree + 2 years experience

Bachelor’s Degree + 4 years experience

Associate Degree + 8 years experience

High School Diploma / GED + 10 years experience

Job description

Title: Specialist – Manufacturing (3455985)

Work Schedule: 100% Onsite – Administrative Shift

Duration: Approximately 6 months

Open to: Residents of Puerto Rico that are U.S. Citizens

SUMMARY

Our client is seeking a Manufacturing Specialist to provide support in the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions.

This position requires a strong foundation in process engineering, operational excellence, and GMP compliance. The selected candidate will apply scientific, technical, and analytical skills to support manufacturing operations, drive process improvements, and ensure regulatory compliance.

The Manufacturing Specialist may serve as a primary process owner for specific systems and assist with process ownership responsibilities on more complex platforms.

PREFERRED QUALIFICATIONS

• Education: Bachelor’s or higher in Engineering, Life Sciences, Biotechnology, Chemistry, or a related technical field.
• Manufacturing Experience: Hands-on experience in process engineering, manufacturing support, or production systems within a regulated environment (pharmaceutical, biotechnology, or medical device).
• Technical Knowledge: Familiarity with automation systems, process equipment, and continuous improvement methodologies such as Lean Six Sigma, Kaizen, and Root Cause Analysis.
• Problem-Solving: Demonstrated ability to troubleshoot manufacturing issues, implement CAPAs, and drive process optimization initiatives.
• Collaboration: Proven success working cross-functionally with operations, quality, and maintenance teams in a fast-paced environment.
• Regulatory / GMP Expertise: Strong understanding of cGMP principles, documentation practices, and regulatory compliance.
• Additional Skills: Excellent communication, adaptability, and attention to detail.

ESSENTIAL FUNCTIONS

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures to ensure they reflect current operations.
• Serve as document owner and ensure procedural compliance across all production activities.
• Assess process performance through observation and data review; implement solutions to improve efficiency and quality.
• Provide troubleshooting support for manufacturing issues.
• Assist in generating and delivering training materials on technical or scientific aspects of manufacturing processes.

Process Monitoring

• Support the establishment of process monitoring parameters and control limits.
• Collect and evaluate process monitoring data and assist in the assessment of deviations.
• Contribute to the timely preparation and completion of process monitoring quarterly reports.

Non-Conformance and CAPA Management

• Ensure all non-conformances are triaged and investigated within established timelines.
• Author thorough investigation reports and ensure execution and closure of corrective actions.
• Monitor trends in non-conformances and CAPAs, providing recommendations for improvement.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Process Validation

• Support the generation and execution of process validation protocols and reports.
• Assist in data collection, analysis, and documentation of process validation activities.

Regulatory and Change Control Support

• Participate in regulatory inspections, new product introductions, and process/equipment modification activities.
• Assess requirements for documentation, materials, training, and equipment modifications related to NPIs.
• Support manufacturing change owners on change control requests impacting the process.

Projects and Initiatives

• Participate in special projects or initiatives focused on process improvements, operational excellence, or compliance enhancement.
• Provide input and support for process or equipment modification projects, including prioritization and implementation.

Note:

Additional duties may be assigned as needed.

EDUCATION AND EXPERIENCE REQUIREMENTS

• 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

CORE COMPETENCIES & SKILLS

• Strong technical understanding of bioprocessing unit operations.
• Demonstrated performance in GMP manufacturing operations.
• Knowledge of regulatory requirements and compliance interactions.Effective participation and leadership in cross-functional teams.
• Excellent communication, documentation, and presentation skills.
• Strong organizational and technical writing abilities.
• Basic project management and data analysis skills, including control charting.