PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking an experienced Validation Specialist with general manufacturing equipment in Raleigh-Durham, NC.
Objectives of this Role:
- Write and execute, Installation Qualification (IQ), and Operational Qualification (OQ) protocols and Summary Reports including thorough resolution of protocol discrepancies.
- Assess potential sources of variation in materials, processes, facilities, equipment, products, and packaging processes that may impact consistent performance or product quality; where needed, design studies to characterize impact of identified sources.
- Maintain an up-to-date knowledge of validation requirements, practices, and procedures.
- Interpret existing Validation Plans and Project Plans and apply concepts to the task at hand.
- Working with a team to ensure all aspects of activity within the Process Development and Validation group adhere to required policies and procedures, including safety and training.
- Investigate/troubleshoot validation problems, as well as, conduct some statistical analysis of testing results.
Skills and Qualifications:
- Bachelor’s degree in a science / engineering field.
- Highly capable of developing, executing, and reviewing validation life cycle protocols.
- Knowledge of validation principles, standard concepts, practices, procedures, and requirements in GMP regulated environments.
- Proven capability to assess processes, equipment, and products for sources of variation, ability to analyze data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.
- Experience with validation and working knowledge of production is a plus.
- Familiarity with FDA regulatory requirements for the Pharmaceutical/biopharmaceutical industry (i.e. GMP and GLP).
- Experience with Microsoft Office Suite.
Why PharmEng Technology?
Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.
What We Have:
- Comprehensive benefits package & competitive wages
- A supportive environment where employee growth is promoted
- PTO & paid holidays
- Other great incentives
Company Response to Covid-19
While we serve industries deemed essential businesses, PharmEng Technology will follow safe business practices and adhere to local, state, and federal guidelines. When possible, PharmEng Technology will allow remote work from home.
At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.