Specialist Manufacturing at BioPharma Consulting JAD Group

Juncos, , Puerto Rico -

Full Time

Start Date

Immediate

Expiry Date

09 Jan, 26

Salary

0.0

Posted On

11 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Understanding of Bioprocessing Unit Operations, GMP Production Experience, Regulatory Knowledge, Strong Communication, Cross-Functional Collaboration, Organizational Skills, Technical Writing, Presentation Skills, Basic Project Management, Control Charting Knowledge, Adaptability, Problem-Solving, Process Troubleshooting, Lean Six Sigma, Root Cause Analysis, CAPA Implementation

Industry

Biotechnology Research

Description

This role is ideal for candidates with hands-on experience in regulated environments (biotech/pharma), strong process troubleshooting skills, and a collaborative mindset. The successful candidate will contribute to non-conformance investigations, process validation, documentation, training, and new product introductions. Key Responsibilities Initiate, revise, and approve manufacturing procedures; serve as document owner. Monitor floor operations and performance data to identify and implement process improvements. Provide technical troubleshooting and support for manufacturing systems. Assist in developing training materials and delivering technical instruction. Support definition of process parameters and control limits. Collect and assess process monitoring data; contribute to quarterly reporting. Triage non-conformances and author investigation reports. Execute corrective actions and ensure timely closure of NC/CAPA. Monitor incident trends and support root cause analysis evaluations. Assist in drafting and executing validation protocols and reports. Support data collection and analysis for validation activities. Participate in regulatory inspections, NPIs, and equipment/process modifications. Support CCRB packages and change control documentation. Contribute to special projects and cross-functional initiatives. Skills Technical understanding of bioprocessing unit operations GMP production experience and regulatory knowledge Strong communication and cross-functional collaboration Organizational, technical writing, and presentation skills Basic project management and control charting knowledge Adaptability and problem-solving in fast-paced environments Qualifications Doctorate OR Master’s + 2 years of manufacturing operations experience OR Bachelor’s + 4 years OR Associate’s + 8 years OR High School/GED + 10 years Academic background in Engineering, Life Sciences, Biotechnology, Chemistry, or related technical discipline Fully bilingual (English/Spanish) Preferred Experience Engineering support in manufacturing operations Familiarity with automation systems and process equipment Experience with Lean Six Sigma, Kaizen, and root cause analysis Proven success in CAPA implementation and process troubleshooting Strong understanding of cGMP, compliance, and documentation practices Effective collaboration with operations, quality, and maintenance teams 6-months contract with possible extension Administrative Shift

Responsibilities

The Specialist Manufacturing will initiate and approve manufacturing procedures, monitor operations for process improvements, and provide technical support. They will also assist in training development, non-conformance investigations, and participate in regulatory inspections.