Job description
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 a Cleaning Validation Specialist for an opportunity in Raleigh-Durham, NC.
Objectives of this Role:
Skills and Qualifications:
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:
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 a Cleaning Validation Specialist for an opportunity in Raleigh-Durham, NC.
Objectives of this Role:
- Design and develop cleaning procedures for new products and manufacturing equipment.
- Provide technical support to cleaning activities associated with the manufacturing process.
- Use of cleaning agents and the establishment of sound cleaning practices within new or existing manufacturing rooms and sampling suites areas.
- Design and support the implementation of cleaning strategies for product transfer projects and product development projects.
- Investigate and conduct troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.
- Lead the enhancement of cleaning practices, “clean in place” equipment and introduction.
- Review and approve Manufacturing Cleaning Working Instructions and Forms.
- Support the periodic review of cleaning validation studies.
- Perform successful and on time resolution of incidents and deviations related to cleaning validation exercises.
- Issue Change Controls required for the implementation of cleaning procedure changes, as needed.
- Train manufacturing and QC/QA personnel on cleaning validation documentation.
Skills and Qualifications:
- Bachelor's or master’s degree in Science, Pharmacy or Engineering.
- Minimum of 3 years of professional experiences in cleaning validation in the pharmaceutical and biotechnology industries.
- Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
- Proficient time management skills, planning and organization capabilities.
- Proven team player, self-starter, results oriented and able to build strong relationships with multiple groups.
- Proficient in Risk Assessment/Management.
- Proven assessment, analytical and problem-solving skills.
- Proficient presentation skills and Technical Writing/Oral communication skills.
- Proficient in cGMP's and FDA Regulations as it applies to pharmaceutical industry.
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
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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