Validation Specialists Job at PharmEng Technology
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 Specialists/Engineers for an opportunity in the Raleigh-Durham, NC area.
Objectives of this Role:
Filling - Packaging Validation:
Skills and Qualifications:
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:
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.
EEOC Statement
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.
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 Specialists/Engineers for an opportunity in the Raleigh-Durham, NC area.
Objectives of this Role:
Filling - Packaging Validation:
- Author, execute, or review Validation documents such as: Validation Project Plans, Qualification Project Plan Reports, Validation Qualification Reports, Validation Qualification Protocols, Risk Management tools, Cleaning Calculations, Formulation Evaluations, and Deviation Handling.
- Support yield improvement efforts as they related to solution loss, overfill, and defects.
- Complete different tasks to support departments on change requests, Non-conformance/CAPA, and operational improvement programs.
- Troubleshoot components and equipment issues to resolve complaints.
- Support the Operational Qualification (OQ) and developed associated documentation.
- Data and test scripts in support of IQ, OQ, & PQ validation milestones.
- Testing in Serialization core system.
- Identify technical issues coming from QA testing.
- Develop test scripts, OQ and capturing and preparing documents for review. Support and assist in the execution of validation strategy and validation master plans.
- Contribute to project URS, FS, DS and validation documents.
- Prepare validation documents: capture functional requirements for the client, change control, standard operating procedures (SOPs) and reports etc.
Skills and Qualifications:
- Minimum of 3 years of experience in qualifying filling/packaging manufacturing equipment and serialization required. 7 years of overall experience is preferred.
- Must have excellent verbal communication and technical writing skills.
- Excellent knowledge of pharmaceutical quality systems and Qualification practices.
- Perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards.
Bachelor's degree in engineering or life sciences discipline or equivalent work experience in the pharma/biotech industries.
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
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.
EEOC Statement
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.
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