Manufacturing Specialist 3070689
Job Title: Specialist Manufacturing
Job ID: 3070689
Location: East of Puerto Rico (Open to Puerto Rico Residents)
Schedule: 100% On-Site, Administrative 8-hour Shift
Position: 1
Duration: Approximately Six Months
Summary
Our client is seeking a Specialist Manufacturing to support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. With minimal supervision, the candidate will apply process, operational, and scientific expertise, as well as compliance knowledge, analytical skills, and troubleshooting abilities to support manufacturing operations. The selected individual may serve as the primary production process owner for process support systems and assist with process ownership responsibilities for more complex systems.
Preferred Qualifications
- Degree in Engineering or Science
- Experience in Technical Writing (SOPs, Forms)
- Knowledge of Change Control Processes
Key Responsibilities
Process Expertise
- Initiate, revise, and approve manufacturing procedures to ensure alignment with current operations.
- Serve as a document owner for process-related documentation.
- Assess process performance by reviewing floor operations and performance data.
- Identify and implement solutions for process improvement opportunities.
- Provide troubleshooting support.
- Assist in generating training materials and conducting technical training.
Process Monitoring
- Support the establishment of process monitoring parameters and control limits.
- Collect and analyze process monitoring data.
- Assist in assessing deviations and contribute to process monitoring reports.
Non-Conformance and CAPA
- Ensure timely triage of non-conformances within established goals.
- Author investigation reports related to non-conformances.
- Execute corrective actions and manage NC/CAPA closures within set deadlines.
- Monitor and communicate trends in incidents.
- Review equipment/system root cause analysis investigations and support trend evaluations.
Process Validation
- Assist in generating process validation protocols and reports.
- Support the execution of process validation activities.
- Collect and analyze process validation data.
Regulatory Compliance
- Participate in regulatory inspections as needed.
New Product Introductions & Equipment Modifications
- Participate in new product introduction (NPI) processes to determine documentation, materials, training, and equipment modification requirements.
- Assess, prioritize, and implement process or equipment modifications, providing project management support as needed.
Change Control
- Assist manufacturing change owners in managing CCRB packages impacting processes.
Projects and Initiatives
- Support the assessment and implementation of special projects or initiatives.
- Perform additional assigned responsibilities as required.
Education & Experience Requirements
- Doctorate degree, OR
- Master's degree with 3 years of manufacturing operations experience, OR
- Bachelor's degree with 5 years of manufacturing operations experience, OR
- Associate’s degree with 10 years of manufacturing operations experience, OR
- High school diploma/GED with 12 years of manufacturing operations experience.
Competencies & Skills
- Strong technical understanding of bioprocessing unit operations.
- Experience in GMP production operations.
- Knowledge of regulatory requirements and interactions.
- Ability to participate in and lead cross-functional teams.
- Strong communication and collaboration skills with technical and management staff in manufacturing, process development, and quality.
- Proficiency in organizational, technical writing, and presentation skills.
- Basic project management skills.
- Fundamental understanding of control charting.
This position offers an opportunity to work in a dynamic and regulated environment, contributing to the efficiency and quality of manufacturing processes. If you meet the qualifications and are looking for an exciting opportunity, we encourage you to apply.
How to Apply
To apply, please submit your updated resume using the following link: https://app.loxo.co/job/MTY0NDYtbmQ5ZTB4ZDllczZjeWlvbA==?t=1741712048319