Manufacturing Specialist (Biotechnology) 215818

ProQuality Network; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

ProQuality Network is seeking a highly skilled Specialist in Manufacturing (Biotechnology) for a 6-month onsite engagement in Juncos, Puerto Rico. The role focuses on manufacturing operations, non-conformances, validation, training, and new product introductions.

The candidate will apply GMP knowledge and cross-functional collaboration to support process improvements and regulatory readiness in a fast-paced environment.

Qualifications

• Proven experience in Manufacturing Operations
• Experience with Change Control and New Product Introduction (NPI)
• Ability to lead cross-functional projects and communicate across teams
• Strong risk assessment and proactive communication

Responsibilities

• Initiate, revise, and approve manufacturing procedures and own documents.
• Establish process monitoring parameters and control limits.
• Investigate non-conformances and drive CAPA closures.
• Support process validation activities and NPI changes.
• Collaborate on process or equipment modifications.
• Contribute to continuous improvement initiatives.

Skills

Manufacturing Operations

Change Control

New Product Introductions (NPI)

Cross-functional teamwork

Risk assessment & issue escalation

Technical writing & training materials

Process validation knowledge

Education

Master’s degree in related field

Bachelor’s degree in related field

Associate degree

High school diploma or GED

Bioprocessing unit operations knowledge

GMP production environments knowledge

Regulatory standards familiarity

Job description

Manufacturing Specialist (Biotechnology) 215818

Title: Specialist Manufacturing (Biotechnology) – 3215818

Location: Juncos, Puerto Rico (Open to Puerto Rico residents only)

Work Setting: 100% Onsite

Shift: 8-hour shift | 8:00 AM – 5:00 PM

Duration: Approximately six (6) months

Positions Available: 1

Summary

Our client, in partnership with ProQuality Network through a contractual engagement, is seeking a highly skilled and motivated Specialist in Manufacturing (Biotechnology). This professional will support the execution of key manufacturing and quality systems with minimal supervision, including non-conformances, process validation, procedure development, training initiatives, and new product introductions.

The selected candidate will apply their scientific, process, and compliance knowledge along with analytical and troubleshooting skills to support manufacturing operations. This role may involve serving as the primary production process owner for designated systems and supporting more complex operations as needed.

Preferred Qualifications

• Proven experience in Manufacturing Operations
• Proficient in managing Change Control processes, particularly those related to New Product Introduction (NPI)
• Demonstrated success in leading projects and ensuring effective communication across cross-functional teams
• Strong risk assessment and issue escalation capabilities, with a proactive communication style

Key Responsibilities

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures and serve as the document owner.
• Ensure procedures accurately reflect current operations.
• Assess floor operations and performance data to identify and implement process improvements.
• Assist in the creation and delivery of technical or scientific training materials.

Process Monitoring

• Establish process monitoring parameters and control limits.
• Collect and analyze monitoring data and support the assessment of deviations.
• Assist in the timely preparation and delivery of quarterly process monitoring reports.

Non-Conformance and CAPA

• Ensure timely triage of non-conformances within established goals.
• Author investigation reports and execute corrective actions.
• Oversee NC/CAPA closures within designated timelines.
• Monitor and communicate trends in incidents.
• Review equipment/system root cause investigations and support trend evaluations.

Process Validation

• Contribute to the development and execution of process validation protocols and reports.
• Support data collection and analysis during validation efforts.Regulatory
• May participate in internal or external regulatory inspections.

New Product Introductions & Process or Equipment Modifications

• Collaborate on NPI processes to define documentation, training, material, and equipment modification needs.
• Provide prioritization, justification, and project management support for process or equipment changes.

Change Control

• Assist as a manufacturing change owner or support CCRB packages affecting the process.

Projects and Initiatives

• Contribute to the assessment and implementation of special projects or continuous improvement initiatives.

Note: Additional responsibilities may be assigned based on project or business needs.

Education / Licenses

• Master’s degree and 3 years of Manufacturing Operations experience; OR
• Bachelor’s degree and 5 years of Manufacturing Operations experience; OR
• Associate degree and 10 years of Manufacturing Operations experience; OR
• High school diploma / GED and 12 years of Manufacturing Operations experience.
• In-depth technical understanding of bioprocessing unit operations
• Strong knowledge and experience in GMP production environments
• Familiarity with regulatory standards and interactions
• Ability to lead or collaborate within cross-functional teams
• Effective communicator with technical and management teams
• Proficient in technical writing, presentations, and organizational skills
• Basic understanding of control charting