Job Description
Job Description
Title: Specialist Manufacturing (3589292)
Location: Juncos, Puerto Rico
Positions: 1
Contract Duration: 6-Month Contract
Work Schedule: Onsite role with 8-hour shifts, including non-standard shifts and overtime based on business needs.
Summary
Our client is seeking a Manufacturing Specialist to support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions.
This role requires applying process, operational, and scientific expertise, along with compliance knowledge, analytical thinking, and troubleshooting skills to support manufacturing operations. The selected candidate may serve as the primary production process owner for support systems and assist with more complex process ownership responsibilities.
Preferred Qualifications
- Experience in manufacturing environments, specifically writing procedures and managing documents within document management systems.
- Strong knowledge of GMP-regulated operations and manufacturing support activities.
Key Responsibilities
Applied Process Expertise
- Initiate, revise, and approve manufacturing procedures, ensuring all procedures accurately reflect current operations.
- Serve as the document owner for assigned procedures and controlled documentation.
- Assess process performance through floor observations and review of operational performance data.
- Identify, evaluate, and implement process improvement opportunities.
- Provide troubleshooting support for manufacturing operations.
- Assist in the development of training materials and provide technical or scientific training when needed.
Process Monitoring
- Support the establishment of process monitoring parameters and control limits.
- Collect process monitoring data and assist in the assessment of process deviations.
- Support the timely execution of quarterly process monitoring reports.
Non-Conformance and CAPA
- Ensure all non-conformances are triaged within established timelines.
- Author investigation reports related to deviations and non-conformances.
- Execute corrective and preventive actions (CAPA) as required.
- Manage non-conformance and CAPA closures within established goals.
- Monitor, analyze, and communicate incident trends.
- Review equipment and system Root Cause Analysis investigations and support trend evaluations.
Process Validation
- Assist in the generation of 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 required.
New Product Introductions & Equipment Modifications
- Participate in New Product Introduction (NPI) activities to assess documentation, material, training, and equipment modification requirements.
- Assess, prioritize, justify, and support implementation of process or equipment modification projects.
- Provide project management support for manufacturing improvement initiatives.
Change Control
- Assist manufacturing change owners with CCRB packages impacting manufacturing processes.
Projects and Initiatives
- Participate in the assessment and implementation of special projects and continuous improvement initiatives.
Additional responsibilities may be assigned as needed.
Education Requirements
Candidates must meet one of the following education and experience combinations:
- 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
Required Competencies and Skills
- Strong technical understanding of bioprocessing unit operations.
- Experience performing GMP production operations.
- Knowledge of regulatory compliance requirements and regulatory interactions.
- Ability to participate in and support cross-functional teams.
- Strong communication and collaboration skills with manufacturing, process development, quality, and management teams.
- Excellent organizational, technical writing, and presentation skills.
- Basic project management skills.
- Basic knowledge of control charting and process monitoring tools.