Manufacturing Specialist- Prqn 787

Tittle: Manufacturing Specialist – PRQN-787

Location: Juncos, Puerto Rico

Work Schedule: Hybrid – Administrative Shift

Availability: Must be available to work different shifts and/or weekends as business needs require

Contract Duration: 5 months

Position Available: 1

Important Notice

This opportunity is available only to direct individual candidates. Submissions from third-party contractors, staffing agencies, vendors, or Corp-to-Corp (C2C) arrangements will not be considered.

Position Summary

Our client is seeking a Manufacturing Specialist to support manufacturing and quality systems with minimal supervision. The individual will provide technical and operational support in areas including non-conformances, CAPA, process validation, manufacturing procedures, training, process monitoring, and New Product Introductions (NPI).

The role requires strong process, operational, and scientific knowledge, along with analytical, troubleshooting, technical writing, and problem-solving skills. The selected candidate may serve as the primary Process Owner for manufacturing process support systems and assist with process ownership responsibilities for more complex systems.

Key Responsibilities

Applied Process Expertise

Initiate, revise, and approve manufacturing procedures, ensuring documentation accurately reflects current operations.
Serve as a Document Owner for applicable manufacturing procedures.
Assess process performance through direct observation of manufacturing floor operations and review of performance data.
Identify process improvement opportunities and evaluate, plan, and implement appropriate solutions.
Provide technical troubleshooting support for manufacturing processes.
Assist with the development of training materials.
Support or provide training on the scientific and technical aspects of manufacturing processes.

Process Monitoring

Support the establishment of process monitoring parameters and control limits.
Collect and analyze process monitoring data.
Support the assessment and evaluation of process deviations.
Support the timely preparation and execution of quarterly process monitoring reports.

Non-Conformances and CAPA

Ensure non-conformances are triaged within established timelines and quality goals.
Author investigation reports and ensure appropriate documentation.
Execute assigned corrective actions.
Manage Non-Conformance/CAPA activities through timely closure.
Monitor and communicate incident and quality trends.
Review equipment and system Root Cause Analysis (RCA) investigations.
Support trend evaluations and identification of recurring issues.

Process Validation

Assist with the development of process validation protocols and reports.
Support the execution of process validation activities.
Assist with the collection, review, and analysis of process validation data.

Regulatory, NPI, and Process/Equipment Modifications

Participate in regulatory inspections, New Product Introductions (NPI), and process or equipment modification activities, as needed.
Participate in NPI activities by assessing requirements related to:
Documentation
Materials
Training
Equipment modifications
Assess, prioritize, and justify process or equipment modification initiatives.
Provide implementation and project management support for process and equipment modification projects.

Change Control

Assist Manufacturing Change Owners with CCRB (Change Control Review Board) packages that impact manufacturing processes.
Support the preparation, review, and progression of change control documentation.

Projects and Initiatives

Participate in the assessment, planning, and implementation of special projects and manufacturing initiatives.
Collaborate with cross-functional teams to support business and operational objectives.

Additional responsibilities may be assigned based on business needs.

Education & Experience

Candidates must meet one of the following 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's degree plus 8 years of Manufacturing Operations experience; or
High School Diploma/GED plus 10 years of Manufacturing Operations experience.

Required Competencies & Skills

Strong technical understanding of bioprocessing unit operations.
Experience supporting or performing GMP manufacturing operations.
Knowledge of applicable regulatory requirements and experience interacting with regulatory functions.
Ability to participate in and support the leadership of cross-functional teams.
Strong communication and collaboration skills when working with Manufacturing, Process Development