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.
- Provide troubleshooting support.
- 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
- Doctorate degree; OR
- 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.
Competencies / Skills
- 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
- Foundational project management experience
- Basic understanding of control charting
📩 We invite qualified candidates to apply by submitting an updated resume through the job description link. Don’t miss the opportunity to be part of a high-impact project in the biotechnology industry!