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Pharmaceutical Engineer III

Gilead Sciences

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Location: Foster City, CA Posted Date: 4/23/2013 Position Type: Full time Job Code: 10805 Required Education: High school or equivalent Areas of Expertise Desired: Engineering

Description

Specific Responsibilities:  
Reporting to the Associate Director, Pharmaceutical Manufacturing, the Pharmaceutical Engineer III works as team member with Formulation and Process Development, Quality Assurance, Materials Management, Regulatory Affairs, Project Management, and staff from other functional areas to meet complex project deliverables such as new product launches or start-up of new manufacturing sites while ensuring uninterrupted commercial product supply.  

Essential Duties and Job Functions:  
• Develops strategies to implement changes to processes.
• Interfaces with contract manufacturers to address standard documentation and compliance issues.
• Contributes to organization processes across functions and interacts effectively with the other team members.
• With guidance, prioritizes own work to ensure conformance to departmental goals.
• Writes internal procedures required to ensure GMP compliance.
• Supports and revises specifications and resolves technical issues with material suppliers.
• Prepares documents for Regulatory filings.
• Responsible for planning and implementing activities on projects related to scale-up, validation, and technology transfer between sites.
• Supports discrete aspects for the specification, installation, utilization, qualification, and improvement of equipment used for solid dose and liquid products.
• May oversee equipment/process qualification (IQ/OQ/PQ) and validation (PV); may write qualification/validation/technical reports.

Requirements

• 6+ years of relevant experience and a BS or BA.
• 4+ years of relevant experience and a MS.
• Prior experience in pharmaceutical industry is preferred.
• Proficient knowledge of Good Manufacturing Practices (GMPs).
• Audit and Investigation Skills, Report Writing Skills.
• Strong verbal, technical writing and interpersonal skills are required.
• Proficiency in Microsoft Office applications.
• Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.
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