Manufacturing Specialist - Regulated Industry (3516867)
Job Description
Job Description
Title: Specialist Manufacturing – Regulated Industry (3516867)
Location: Puerto Rico
(Open to residents of Puerto Rico)
Work Arrangement: Virtual/Remote (availability to work onsite as needed)
Work Schedule: Administrative Shift
Employment Type: Contract
Duration: Approximately six (6) months
Positions Available: 1
Position Summary
Our client is seeking a Specialist Manufacturing – Regulated Industry to support manufacturing and quality systems with minimal supervision. This role will contribute to the execution of non-conformance management, process validation, procedure development, training, and new product introductions. The selected candidate will apply process, operational, scientific, and compliance expertise to support manufacturing operations and may serve as a primary production process owner for select systems.
Preferred Qualifications
Educational background in Science or Industrial Engineering preferred
Experience in manufacturing, process development, or quality assurance within the biotech or pharmaceutical industry, with progressive responsibility
Demonstrated experience in compliance, problem-solving, critical thinking, project management, and quality systems
Professional Skills & Experience
Project and/or Quality Management experience with the ability to coordinate and actively participate in cross-functional teams
Proven ability to manage multiple, competing priorities in a fast-paced environment with minimal direction
Strong written and verbal communication skills in English, including technical writing and presentations
Ability to work autonomously, prioritize tasks, meet deadlines, and present data clearly and logically
Capability to navigate ambiguity and apply structured problem-solving methodologies
Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Project, Teams, Outlook)
Experience managing quality records such as deviations, CAPAs, change controls, and supplier investigations using TrackWise, Veeva, or comparable quality systems
Experience executing transactions in SAP (ERP) systems
Strong negotiation and influencing skills with peers, leadership, suppliers, and cross-functional stakeholders
Ability to maintain effective working relationships in a remote environment
Key Responsibilities
Applied Process Expertise
Initiate, revise, and approve manufacturing procedures; ensure alignment with current operations
Serve as document owner for assigned procedures
Assess process performance through floor observations and data review
Identify, plan, and implement process improvement initiatives
Provide technical troubleshooting support
Assist in the development of training materials and delivery of technical training
Process Monitoring
Support establishment of process monitoring parameters and control limits
Collect and analyze process monitoring data
Support deviation assessments and timely completion of quarterly process monitoring reports
Non-Conformance & CAPA Management
Ensure timely triage of all non-conformances
Author investigation reports and execute corrective actions
Manage NC/CAPA closure within established timelines
Monitor, trend, and communicate incident data
Review equipment and system Root Cause Analysis investigations and support trend analysis
Process Validation
Assist in the development of process validation protocols and reports
Support execution of validation activities
Collect, analyze, and interpret process validation data
Regulatory & Compliance Support
Participate in regulatory inspections, new product introductions, and process or equipment modifications as needed
Support NPI activities, including assessment of documentation, materials, training, and equipment requirements
Assess, prioritize, and support implementation of process or equipment modification projects
Change Control
Support manufacturing change owners with Change Control Review Board (CCRB) packages impacting processes
Projects & Initiatives
Participate in special projects and continuous improvement initiatives
Perform other 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
Core Competencies & Skills
Strong technical understanding of bioprocessing unit operations
Hands-on experience performing GMP manufacturing operations
Knowledge of regulatory requirements and inspection readiness
Ability to participate in and support cross-functional teams
Strong communication and collaboration skills across manufacturing, process development, and quality organizations
Effective organizational, technical writing, and presentation skills
Basic project management capabilities
Foundational knowledge of process monitoring and control charting
Apply Now
Qualified candidates are encouraged to apply directly through the job description link and submit an updated resume highlighting relevant regulated manufacturing, quality systems, and GMP experience.