With minimal supervision, the Specialist Manufacturing supports the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions (NPI).
This role applies process, operational, and scientific expertise along with compliance knowledge and analytical troubleshooting skills to support manufacturing operations. The specialist may serve as a primary process owner for defined systems and assist with more complex process ownership responsibilities.
Key Responsibilities
- Initiate, revise, and approve manufacturing procedures; ensure alignment with current operations.
- Serve as document owner for assigned procedures.
- Monitor process performance through floor observation and data analysis.
- Identify, evaluate, and implement process improvements.
- Provide technical troubleshooting support.
- Assist in development of training materials and support delivery of technical training.
- Support establishment of process monitoring parameters and control limits.
- Collect and analyze process monitoring data.
- Assist in deviation assessments and trend evaluations.
- Support timely execution of quarterly process monitoring reports.
- Ensure timely triage of non-conformances within established goals.
- Author investigation reports and support root cause analysis.
- Execute corrective and preventive actions (CAPAs).
- Manage closure of NC/CAPA records within required timelines.
- Monitor and communicate incident trends.
- Review equipment/system investigations and support trend analysis.
- Assist in development of process validation protocols and reports.
- Support execution of validation activities.
- Collect and analyze validation data.
- Participate in regulatory inspections and audits as needed.
- Support NPI activities by assessing documentation, materials, training, and equipment needs.
- Assist with process and equipment modification projects.
- Support prioritization, justification, and implementation of changes.
- Support change control activities and assist manufacturing change owners with CCRB packages.
- Participate in special projects and continuous improvement initiatives.
- Support cross-functional project execution.
Requirements
- Doctorate, OR
- Master’s degree + 2 years of Manufacturing Operations experience, OR
- Bachelor’s degree + 4 years of Manufacturing Operations experience, OR
- Associate’s degree + 8 years of Manufacturing Operations experience, OR
- High School Diploma/GED + 10 years of Manufacturing Operations experience
Preferred Qualifications
- Experience in biotech or pharmaceutical manufacturing, process development, or quality assurance.
- Demonstrated experience with:
- Deviations, CAPAs, and Change Controls
- Quality systems and compliance
- Root cause analysis and structured problem solving
- Experience owning and managing Change Controls.
- Strong project management and quality management experience.
- Strong written and verbal communication skills (English).
- Experience with:
- TrackWise, Veeva, or similar quality systems
- SAP (ERP systems)
- Microsoft Office Suite (Word, Excel, PowerPoint, Project, Teams, Outlook)
Benefits
- Contract Position
- 5-months
Top Skills
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results. Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields. We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions. BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
