Specialist Manufacturing 2966659
Specialist Manufacturing Opportunity
Title: Specialist Manufacturing (Job ID: 2966659)
Location: Juncos, PR (Open to U.S. Citizens residing in Puerto Rico)
Work Schedule: 100% Onsite, 8:00 AM – 5:00 PM (8-hour shift)
Positions Available: 1
Duration: Approximately 8 months
Summary
Join our client’s team as a Specialist Manufacturing, where you will support the execution of manufacturing and quality systems with minimal supervision. In this role, you’ll manage non-conformances, process validations, procedures, training, and new product introductions. You will leverage your process expertise, operational knowledge, and compliance understanding to support manufacturing operations effectively.
As a key contributor, you may serve as the primary production process owner for various support systems, as well as assist with more complex process systems when necessary.
Educational and 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.
Preferred Qualifications
- Proficiency in Veeva, Trackwise, CAPA, and Change Control systems.
Key Responsibilities
1. Applied Process Expertise
- Initiate, revise, and approve manufacturing procedures, ensuring alignment with current operations.
- Assess process performance through observation and data analysis; identify and implement process improvement opportunities.
- Provide troubleshooting support.
- Assist in the creation and delivery of training materials related to scientific or technical processes.
2. Process Monitoring
- Establish process monitoring parameters and control limits.
- Collect and evaluate process-monitoring data and deviations.
- Support the timely completion of quarterly process monitoring reports.
3. Non-Conformance and CAPA Management
- Triage non-conformances within defined timelines.
- Author investigation reports and execute corrective actions.
- Manage NC/CAPA closures and communicate incident trends.
- Support Root Cause Analysis and trend evaluations for equipment/systems.
4. Process Validation
- Assist in drafting and executing process validation protocols and reports.
- Collect and analyze validation data to ensure compliance.
5. Regulatory Compliance
- Participate in regulatory inspections as required.
6. New Product Introductions & Process/Equipment Modifications
- Evaluate documentation, materials, training, and equipment needs for new product introductions (NPIs).
- Provide project management support for process or equipment modification initiatives.
7. Change Control Management
- Assist with CCRB packages impacting manufacturing processes.
8. Projects and Initiatives
- Participate in special projects or initiatives as assigned.
Competencies and Skills
- Strong technical understanding of bioprocessing unit operations.
- Proficiency in GMP production operations.
- Familiarity with regulatory compliance and inspection processes.
- Team collaboration and leadership abilities in cross-functional environments.
- Exceptional communication, organizational, and technical writing skills.
- Basic project management expertise and control charting knowledge.
Why Apply?
This is an excellent opportunity to contribute to a cutting-edge manufacturing environment while expanding your expertise in a dynamic and impactful role.
📢 Submit your updated resume today inside job description.
We look forward to reviewing your application!