Manufacturing Specialist II

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Job Description
The Manufacturing Specialist II will play a key part in the facility start up with primary responsibilities focused around supporting daily manufacturing operations on the nested line and the timely production of pharmaceuticals at the Virginia site. This key position will support manufacturing production execution, running equipment, change management, investigations, training, and development. The ideal candidate will have a consistent track record of achieving results in a face-paced manufacturing environment.
Essential Duties and Responsibilities:

• Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety and other cross-functional teams to meet production needs.
• Support onboarding and provide technical training of Manufacturing Operators on process equipment including Fillers with integrated Isolators, ATEC commodities processing, Parts Washer, Autoclaves, Single Use Technology, and Aseptic Process Simulations.
• Initiate and complete manufacturing investigations including root cause analysis and product impact assessment.
• Drive the creation, revision, and management of manufacturing documents such as Batch Records and SOPs.
• Lead efficient GMP document and record reviews to minimize routing time.
• Provide technical expertise and support to production teams, addressing issues and challenges as they arise.
• Supports regulatory inspections as an SME for the area.
• Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions with the intent to minimizing impact to operations.
• Onsite presence, as the role requires time on the manufacturing floor and cross-functional collaboration.
• Develop and track KPI metrics to identify opportunities, failure points, and trending models

Basic Qualifications and Capabilities:

• Associate degree with 6+ years demonstrated ability in a cGMP production environment.
• High School degree with 8+ years of experience of cGMP production experience may be considered.
• Experience with sterile fill finish manufacturing.
• Detailed-oriented with a focus on accuracy in creating and updating production documents.
• Knowledge of GMP, regulatory requirements, and industry best practices.
• Proficiency in Microsoft Office suite.
• Strong communication and collaboration skills, with a commitment to meeting high-quality standards.
• Must be able to complete eye exam and have the visual ability to detect defects.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Basic math skills to perform required calculations (multiplication/division),
• Good deviation and investigation writing skills.
• Ability to work autonomously and within established guidelines, procedures, and practices.

Preferred Qualifications:

• Knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
• Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
• Equipment qualification experience.
• Experience in using ERP systems.

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