Specialist Manufacturing at BioPharma Consulting JAD Group

Juncos, , Puerto Rico -

Full Time

Start Date

Immediate

Expiry Date

01 Aug, 26

Salary

0.0

Posted On

03 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Bioprocessing, GMP, Technical writing, Troubleshooting, Process validation, CAPA, Root cause analysis, Regulatory compliance, Document control, Data analysis, Project management, Quality systems, Change control, Training development, Cross-functional collaboration

Industry

Biotechnology Research

Description

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. This role applies technical, operational, and scientific expertise to support manufacturing operations, troubleshoot issues, and drive continuous improvement. May serve as a process owner for specific systems and support more complex process ownership activities. Key Responsibilities Initiate, revise, and approve manufacturing procedures, ensuring alignment with current operations Serve as document owner for controlled procedures Monitor and assess process performance through floor observation and data analysis Identify and implement process improvements Provide technical troubleshooting support for manufacturing operations Assist in developing and delivering technical training materials Support establishment of process monitoring parameters and control limits Collect and analyze process monitoring data Support deviation assessment and quarterly process monitoring reports Ensure timely triage of non-conformances Author investigation reports and support root cause analysis Execute and track corrective and preventive actions (CAPA) Manage NC/CAPA closure within established timelines Monitor and communicate trend data and recurring issues Review equipment/system investigations and support trend evaluations Assist in development of process validation protocols and reports Support execution of process validation activities Collect and analyze validation data Support and participate in regulatory inspections Ensure adherence to GMP and quality standards Participate in NPI activities, assessing requirements for documentation, materials, training, and equipment Support process and equipment modifications, including project coordination Assist with Change Control (CCRB) activities impacting manufacturing processes Participate in special projects and site initiatives Support implementation of process improvements and operational efficiencies Education & Experience Doctorate degree 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 Required Skills & Competencies Strong understanding of bioprocessing unit operations Experience in GMP manufacturing environments Knowledge of regulatory requirements and compliance practices Ability to troubleshoot manufacturing processes and drive solutions Strong technical writing, documentation, and presentation skills Effective communication and collaboration across manufacturing, quality, and process development teams Basic project management skills Knowledge of control charting and process monitoring tools Ability to participate in and lead cross-functional teams Strong organizational and problem-solving skills Preferred Qualifications Experience with deviation documentation and investigation processes Strong knowledge of Change Control management Experience supporting CAPA systems and continuous improvement initiatives Work Schedule Administrative Shift: Standard business hours Overtime: May be required based on business needs

Responsibilities

The Specialist supports manufacturing operations by managing quality systems, non-conformances, and process validation activities. They are responsible for troubleshooting issues, driving continuous improvement, and ensuring adherence to GMP and regulatory standards.