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Pharmaceutical process engineer skills for your resume and career
6 pharmaceutical process engineer skills for your resume and career
1. FDA
The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.
- Developed and reviewed operations standards procedures for manufacturing equipment and processes to comply with company standards and FDA regulations.
- Completed process qualification of manufacturing line for newest generation pacemaker resulting in successful early FDA acceptance.
2. GMP
GMP stands for Good Manufacturing Practice. It is a system that ensures that all products like food, beverages, and medicinal drugs that are produced comply with the quality standards. It helps in minimizing the risks and hazards that cannot be eliminated after the testing of final products.
- Supported or performed site non-routine GMP training or awareness training sessions related to exceptions/investigations or complaints.
- Lead GMP manufacturing and packaging of clinical supplies in support of global clinical development and regulatory filings.
3. Pharmaceutical Products
- Scoped, Specified and purchased packaging systems for liquids and solids pharmaceutical products.
- Maintained and processed all pharmaceutical products in the OTC retail environment.
4. FMEA
- Reviewed, updated FMEA and reliability/cGMP quality documents; Authored detailed investigation reports.
- Generated FMEA (Failure Mode & Effect Analysis) and process evaluation and recommendations for supporting manufacturing failure investigation activities.
5. Engineering Support
Engineering support means providing assistance to different engineers working in the company. It enables them to complete their tasks effectively and timely. Engineering support revolves around diagnosing and resolving software and hardware problems. They also look for network issues and resolve them in a timely manner.
- Provided Equipment Engineering Support and Equipment Installations for advanced Manufacturing Process Control initiatives and to support increased production utilization and planning.
- Provided on-site engineering support for six-week plant turnaround resulting in on-time delivery of reactor modifications and a successful catalyst change-out.
6. CAPA
- Performed manufacturing investigations and facilitated CAPA plans for solid dosage products.
- Improved awareness of CAPA trends that significantly impacted manufacturing.
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List of pharmaceutical process engineer skills to add to your resume
The most important skills for a pharmaceutical process engineer resume and required skills for a pharmaceutical process engineer to have include:
- FDA
- GMP
- Pharmaceutical Products
- FMEA
- Engineering Support
- CAPA
Updated January 8, 2025