Specialist Manufacturing (3122529)
Job Title: Specialist Manufacturing (3122529)
Location: East of Puerto Rico (Open to Puerto Rico Residents)
Work Arrangement: 100% Onsite
Positions Available: 1
Duration: Approximately Eight Months
Job Summary
Under minimal supervision, the Specialist Manufacturing supports the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. This role applies process, operational, and scientific expertise, along with compliance knowledge and analytical and troubleshooting skills, to support manufacturing operations. The Specialist may serve as the primary production process owner for process support systems and assist with process ownership responsibilities for more complex process systems.
Preferred Qualifications
- Experience in document revision, non-conformances, and change control.
Key Responsibilities
Applied Process Expertise
- Initiate, revise, and approve manufacturing procedures to ensure alignment with current operations. Serve as a document owner.
- Assess process performance by observing floor operations and reviewing performance data. Identify, plan, and implement process improvement solutions.
- Provide troubleshooting support.
- Assist in generating training materials and, when necessary, provide training on scientific or technical aspects of the process.
Process Monitoring
- Support the establishment of process monitoring parameters and control limits.
- Collect process-monitoring data and assist in deviation assessments.
- Support timely execution of quarterly process monitoring reports.
Non-Conformance and CAPA Management
- Ensure all non-conformances are triaged within established goals.
- Author investigation reports.
- Execute corrective actions.
- Manage NC/CAPA closure within established timeframes.
- Monitor and communicate incident trends.
- Review equipment/system root cause analysis investigations and support trend evaluations.
Process Validation
- Assist in generating process validation protocols and reports.
- Support process validation execution.
- Collect and analyze process validation data.
Regulatory Compliance
- Participate in regulatory inspections as needed.
New Product Introductions & Process/Equipment Modifications
- Participate in the New Product Introduction (NPI) process to assess documentation, materials, training, and equipment modification requirements.
- Assess, prioritize, justify, and provide implementation and project management support for process or equipment modifications.
Change Control
- Assist the manufacturing change owner with Change Control Review Board (CCRB) packages impacting processes.
Projects and Initiatives
- Participate in the assessment or implementation of special projects or initiatives.
Additional responsibilities may be assigned as needed.
Education & Experience Requirements
- Doctorate degree OR
- Master’s degree and 3 years of Manufacturing Operations experience OR
- Bachelor’s degree and 5 years of Manufacturing Operations experience OR
- Associate’s degree and 10 years of Manufacturing Operations experience OR
- High school diploma/GED and 12 years of Manufacturing Operations experience.
Competencies & Skills
- In-depth technical knowledge of bioprocessing unit operations.
- Strong proficiency in GMP production operations.
- Familiarity with regulatory requirements and interactions.
- Ability to participate in and help lead cross-functional teams.
- Strong communication and collaboration skills with technical and management staff in manufacturing, process development, and quality.
- Excellent organizational, technical writing, and presentation skills.
- Basic project management capabilities.
- Fundamental knowledge of control charting.
This is an exciting opportunity to contribute to a regulated industry while gaining valuable experience in manufacturing operations. If you meet the qualifications and are eager to make an impact, we encourage you to apply using the job description link and submit your updated resume.**