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 Cleaning Validation Specialist with solid experience in equipment qualification and pharmaceutical solutions in Life Science industries for a role in Singapore.
Objectives of this Role:
A Cleaning Validation Specialist is responsible for ensuring that cleaning procedures for equipment and facilities in highly regulated industries, such as pharmaceuticals, biotechnology, and medical devices, are effective and meet regulatory requirements. The job description for a Cleaning Validation Specialist may include the following responsibilities:
Develop and execute cleaning validation protocols for equipment and facilities to ensure they are cleaned to appropriate levels and are free from contamination.
Perform risk assessments and develop risk-based cleaning validation plans to ensure equipment and facilities are cleaned to appropriate levels.
Develop and implement cleaning procedures, methods, and acceptance criteria for equipment and facilities to ensure consistent and effective cleaning.
Review and approve cleaning validation protocols, reports, and related documentation.
Work collaboratively with cross-functional teams, including manufacturing, quality assurance, and engineering, to ensure compliance with regulatory requirements and industry standards.
Investigate and troubleshoot cleaning validation issues and provide recommendations for corrective and preventive actions.
Stay current with industry trends, regulations, and best practices related to cleaning validation.
Skills and Qualifications:
- Bachelor's or Master's degree in Chemistry, Pharmacy, Chemical Engineering, or any related field.
- Solid 3 and up years of experience with specific experience within (bio) pharmaceutical (or related industries) and GMP is desirable; Junior with a minimum of 2 years is welcome to apply.
- Proven experience in cleaning validation in a regulated industry is highly valued.
- Has a knowledge in regulatory requirements such as FDA, GMP, and ISO.
- Excellent communication skills, attention to detail, and problem-solving skills are also important for this role.
- Proficient in English, both in speaking and in writing.
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 PharEng 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.
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.
