Manufacturing Specialist (3522284) Regulated Industry
Job Title: Specialist, Manufacturing (3522284)
Location: East Region, Puerto Rico (Open to Puerto Rico Residents)
Work Schedule: 100% Onsite – Administrative Shift
Open Positions: 5
Assignment Duration: Approximately 11 months
Position Summary
Under minimal supervision, the Manufacturing Specialist supports the execution and continuous improvement of manufacturing and quality systems, including non-conformance management, process validation, procedures, training, and new product introductions. This role applies process, operational, and scientific expertise, along with foundational compliance knowledge and strong analytical and troubleshooting skills, to support manufacturing operations. The Specialist may serve as a primary production process owner for designated process support systems and assist with process ownership responsibilities for more complex manufacturing systems.
Preferred Qualifications
- Bachelor’s degree in Science or Engineering (preferred)
- Previous manufacturing experience in a regulated environment
- Hands-on experience managing CAPA and Change Control processes
- Experience with document revisions and document ownership
- Proficiency with Veeva systems
Key Responsibilities
Applied Process Expertise
- Initiate, revise, and approve manufacturing procedures, ensuring alignment with current operations.
- Serve as document owner for assigned manufacturing documentation.
- Assess process performance through floor observations and review of performance metrics.
- Identify, evaluate, and implement process improvement opportunities.
- Provide technical and operational troubleshooting support.
- Assist in the development of training materials and support delivery of training on scientific or technical process topics.
Process Monitoring
- Support the establishment of process monitoring parameters and control limits.
- Collect and analyze process monitoring data and support deviation assessments.
- Support the timely execution and completion of quarterly process monitoring reports.
Non-Conformance and CAPA Management
- Ensure all non-conformances are triaged within established timelines.
- Author investigation reports and supporting documentation.
- Execute assigned corrective and preventive actions.
- Manage NC/CAPA activities to closure within established goals.
- Monitor, trend, and communicate incident and deviation trends.
- Review equipment and system root cause analysis investigations and support trend evaluations.
Process Validation
- Assist in the development of process validation protocols and final reports.
- Support execution of process validation activities.
- Collect, analyze, and summarize process validation data.
Regulatory and Compliance Support
- Participate, as needed, in regulatory inspections, new product introductions (NPI), and process or equipment modifications.
- Support the NPI process by assessing requirements related to documentation, materials, training, and equipment changes.
- Assess, prioritize, justify, and support implementation of process or equipment modification projects, including project management support.
Change Control
- Assist manufacturing change owners with Change Control Review Board (CCRB) packages impacting manufacturing processes.
Projects and Initiatives
- Participate in the assessment, planning, and implementation of special projects and continuous improvement initiatives.
- Perform additional related duties as assigned.
Education Requirements
- 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/GED plus 10 years of Manufacturing Operations experience
Competencies and Skills
- Detailed technical understanding of bioprocessing unit operations
- Proficiency in GMP manufacturing and production operations
- Knowledge of regulatory requirements and inspection support
- Ability to participate in and support cross-functional teams
- Strong communication and collaboration skills with technical and management stakeholders
- Effective organizational, technical writing, and presentation skills
- Basic project management capabilities
- Working knowledge of control charting and process trending
Interested candidates are encouraged to apply through the job description link and submit an updated resume for consideration.