Manufacturing Technical Specialist (Biologics Environment)
Manufacturing Technical Specialist (Biologics Environment)
📍 Location: Maryland, USA (Open to Local Candidates)
📅 Duration: 1 Year – Onsite
🕗 Schedule: Monday–Friday, 8 AM – 5 PM
Position Summary
Our client is seeking a Manufacturing Technical Specialist to support Manufacturing Management and Associates in meeting batch record review and disposition schedules to adhere to lot release dates. This role is responsible for executing root cause investigations, authoring deviations, driving continuous improvement initiatives, and revising GMP documents, including SOPs and batch records.
This position is critical to patient safety, ensuring the manufacturing of life-saving medicines is performed right the first time with a focus on quality, safety, and on-time delivery.
Key Responsibilities
- Deviation Investigations & CAPAs:
- Initiate quality records and conduct deviation investigations aligned with industry standards.
- Lead and manage root cause analysis, assessing product impact in collaboration with cross-functional teams.
- Develop, execute, and oversee Corrective and Preventive Actions (CAPAs).
- Process & Documentation Support:
- Support technology transfer and process monitoring efforts.
- Monitor critical process parameters to ensure compliance.
- Author and revise Batch Records, SOPs, and other GMP documents.
- Lead or support continuous improvement projects to enhance manufacturing processes.
- Collect, analyze, and present data to support investigations.
- Provide real-time, on-the-floor response to operational deviations by gathering critical information and documenting initial event reports.
Required Qualifications
- Education & Experience:
- Bachelor’s degree in Science or Engineering with 4+ years of technical experience in biopharmaceutical manufacturing within a GMP-compliant environment.
- Hands-on experience in Production, Development, Process Engineering, or Technical Services.
- Technical Expertise:
- Prior experience operating biopharma equipment, including:
- Incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers, and in-process testing equipment.
- 3+ years of experience in process deviation investigations and remediation.
- Strong familiarity with root cause analysis methodologies (e.g., 5 Whys, Fishbone).
- Ability to conduct interviews for deviation investigations.
- Previous experience authoring and revising technical documents.
- Capability to support and/or lead system troubleshooting efforts.
Key Leadership Attributes
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops Others
Position Benefits
- Career Growth: Potential for advancement within an expanding team.
- Structured Development: Defined career path with annual performance reviews and feedback.
- Cross-Functional Exposure: Opportunity to collaborate with other departments.
- Cutting-Edge Experience: Work in the growing field of gene therapy.
This is an excellent opportunity for professionals looking to enhance their expertise in a biologics environment while contributing to the production of life-saving therapies.
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