Packaging Engineer II
Specific Job Responsibilities
- 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.
- Interfaces with vendors to develop alternate designs of packaging components and translate into actionable specs.
- May take primary role in technical investigations and assessment of deviations particularly as related to data generation/gathering and analysis.
- Travels to Contract packaging sites to oversee qualification activities.
Knowledge & Skills
- Knowledge of the FDA and cGMP standards as well as regulatory guidance documents.
- Audit and investigation skills, report writing skills.
- Strong verbal, technical writing and interpersonal skills.
- Proficiency in Microsoft Office applications.
Required Education & Experience
- A Bachelor’s Degree and a minimum of two (2) years of relevant industry experience, OR A Master’s Degree.
Preferred Experience
- Prior knowledge of packaging equipment related to sterile packaging activities.
- Experience in solid dose and/or vials packaging.
- Experience in the pharmaceutical industry.
About Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.