Specialist Manufacturing
Specialist Manufacturing Opportunity
Location: Juncos, PR (100% Onsite)
Shift: Administrative (8 hours)
Duration: Approximately 11 months
Positions Available: 1
Summary
Join our client’s team as a Specialist Manufacturing, where you will play a pivotal role in supporting manufacturing and quality systems. This includes handling non-conformances, process validation, procedures, training, and new product introductions. With minimal supervision, you will apply your expertise in process operations, scientific knowledge, compliance, and analytical troubleshooting to drive manufacturing excellence.
As a key contributor, you may serve as the primary production process owner for various systems and support complex process systems as needed.
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
- Experience in Change Control Management and Project Management.
- Hands-on experience managing CAPAs in manufacturing environments.
- Proficiency in documenting deviations when required.
- Knowledge of Risk Management practices.
Key Responsibilities
1. Applied Process Expertise
- Initiate, revise, and approve manufacturing procedures to reflect current operations; serve as a document owner.
- Assess process performance by observing operations and reviewing performance data; plan and implement process improvements.
- Provide troubleshooting support.
- Assist in creating training materials and delivering process-specific training as needed.
2. Process Monitoring
- Support the establishment of process monitoring parameters and control limits.
- Collect and assess process-monitoring data and evaluate deviations.
- Contribute to the timely execution of process monitoring quarterly reports.
3. Non-Conformance and CAPA Management
- Triage non-conformances within established timelines.
- Author investigation reports and execute corrective actions.
- Manage NC/CAPA closures and monitor incident trends.
- Support Root Cause Analysis and trend evaluations for equipment/systems.
4. Process Validation
- Assist in creating and executing process validation protocols and reports.
- Collect and analyze validation data.
5. Regulatory Compliance
- Participate in regulatory inspections as required.
6. New Product Introductions (NPI) & Process or Equipment Modifications
- Evaluate requirements for documentation, materials, training, and equipment modifications during NPIs.
- Provide project management support for process or equipment modifications.
7. Change Control Management
- Support manufacturing change owners with CCRB packages impacting processes.
8. Projects and Initiatives
- Participate in special projects or initiatives as assigned.
Competencies and Skills
- Strong technical understanding of bioprocessing unit operations.
- Expertise in GMP production operations.
- Regulatory knowledge and ability to interact with regulatory bodies.
- Teamwork and leadership in cross-functional environments.
- Excellent communication, organizational, technical writing, and presentation skills.
- Basic project management and control charting knowledge.
Why Apply?
This opportunity allows you to leverage your skills in a dynamic, fast-paced manufacturing environment while contributing to high-impact projects. To apply and take the next step in your career, submit your updated resume via the link below:
👉 https://app.loxo.co/job/MTY0NDYtYnFmdmk4dHZtbTZobzdxNQ==?t=1737465400733
We look forward to considering your application!