Title: Specialist Manufacturing ProQN937

Location: Juncos, Puerto Rico (Open to Puerto Rico Residents Only)

Work Arrangement: Onsite

Work Schedule: Administrative Shift, with availability to work non-standard shifts based on business needs

Number of Positions: 1

SUMMARY

With minimal supervision, the Specialist Manufacturing will support the execution and maintenance of manufacturing and quality systems, including non-conformances, process validation, manufacturing procedures, training, and new product introductions (NPI).

The role requires applying process and operational expertise, scientific knowledge, basic compliance principles, analytical thinking, and troubleshooting skills to support manufacturing operations. The selected candidate may serve as the primary production process owner for assigned process support systems and assist with process ownership responsibilities for more complex systems.

PREFERRED QUALIFICATIONS

• Previous manufacturing experience pharmaceutical or biotechnology industries.
• Experience providing on-the-floor support and assessing process performance through direct observation of manufacturing operations and review of performance data.
• Ability to initiate, revise, and approve manufacturing procedures.
• Experience providing process troubleshooting support.
• Participation in New Product Introduction (NPI) activities, including the assessment of documentation, material, and training requirements.
• Experience assisting manufacturing change owners with Change Control Review Board (CCRB) packages impacting manufacturing processes.
• Participation in the assessment and implementation of special projects or process improvement initiatives.

FUNCTIONS

Applied Process Expertise

1. Initiate, revise, and approve manufacturing procedures, ensuring all documentation accurately reflects current manufacturing operations. Serve as a document owner when assigned.
2. Assess process performance through direct observation of floor operations and review of performance data. Evaluate, plan, and implement solutions to address process improvement opportunities.
3. Provide technical troubleshooting support to resolve manufacturing process issues.
4. Assist in developing training materials and, when needed, provide training on the scientific and technical aspects of manufacturing processes.

Process Monitoring

1. Support the establishment of process monitoring parameters and control limits. Collect process monitoring data and assist in evaluating process deviations.
2. Support the timely preparation and execution of quarterly process monitoring reports.

Non-Conformance and CAPA

1. Ensure non-conformances are triaged within established timelines and performance targets.
2. Author investigation reports and ensure appropriate documentation of investigation findings.
3. Execute assigned corrective actions.
4. Manage non-conformance (NC) and Corrective and Preventive Action (CAPA) activities to ensure closure within established timelines.
5. Monitor and communicate incident trends.
6. Review root cause analysis (RCA) investigations involving equipment and systems and support trend evaluations.

Process Validation

1. Assist in the preparation of process validation protocols and reports.
2. Support the execution of process validation activities.
3. Assist with the collection and analysis of process validation data.

Regulatory Support and New Product Introductions

1. May participate in regulatory inspections, New Product Introductions (NPI), and process or equipment modification activities.
2. Participate in the NPI process by assessing requirements related to documentation, materials, training, and equipment modifications.
3. Assess, prioritize, and justify process or equipment modification initiatives while providing implementation and project management support.

Change Control

1. Assist manufacturing change owners with the preparation and coordination of Change Control Review Board (CCRB) packages affecting manufacturing processes.

Projects and Initiatives

1. Participate in the assessment and implementation of special projects and operational initiatives.

Additional responsibilities may be assigned based on business needs.

EDUCATION

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

• Doctorate degree; OR
• Master's degree plus 2 years of Manufacturing Operations experience; OR
• Bachelor's degree plus 4 years of Manufacturing Operations experience; OR
• Associate degree plus 8 years of Manufacturing Operations experience; OR
• High school diploma or GED plus 10 years of Manufacturing Operations experience.

COMPETENCIES / SKILLS

• Detailed technical understanding of bioprocessing unit operations.
• Proficiency in performing GMP manufacturing and production operations.
• Knowledge of regulatory requirements and experience supporting regulatory interactions.
• Ability to participate in and help lead cross-functional teams.
• Strong communication and collaboration skills, with the ability to work effectively with technical and management personnel across Manufacturing, Process Development, and Quality.
• Strong organizational, technical writing, and presentation skills.
• Basic project management knowledge and skills.
• Basic knowledge of statistical process control (SPC) and control charting.