- Experience
- Any
- Salary
- —
- Openings
- 1
- Posted
- 1 வாரம் முன்
- Work mode
- In office
- Education
- Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences or related
- Resume
- Required to apply
Where you'll work
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Job description
About the Role
We are looking for a Cleaning Validation Specialist to take charge of and assist in cleaning validation procedures for manufacturing equipment and processes within a GMP-compliant setting. This position requires developing and implementing cleaning validation plans, critically assessing documentation, performing risk analyses, and assuring adherence to GMP, GDP, and data integrity standards.
Key Responsibilities
- Lead and support cleaning validation and qualification processes across manufacturing equipment and protocols.
- Develop, evaluate, and execute cleaning validation protocols, strategies, and documentation reports.
- Facilitate technical discussions concerning cleaning methodologies, acceptance criteria, sampling approaches, and validation justifications.
- Review and assess cleaning procedures, methods, and equipment sanitation practices.
- Assist in risk evaluations related to product residue, cross-contamination risks, equipment design issues, and effectiveness of cleaning.
- Set or review limits for acceptance, worst-case product selections, residue thresholds, and location of sampling points.
- Collaborate closely with teams from Manufacturing, Quality Assurance, Validation, Engineering, and Quality Control.
- Ensure that documentation complies with GMP, GDP guidelines, data integrity protocols, and site-specific quality standards.
- Identify deficiencies in current cleaning validation procedures and propose practical enhancements.
- Provide support for audit preparedness and respond to queries concerning cleaning validation during inspections or internal reviews.
Candidate Profile
- Possess a bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a comparable field.
- Demonstrate substantial experience in cleaning validation or qualification within pharmaceutical, biotechnology, or GMP-controlled manufacturing contexts.
- Have in-depth knowledge of cleaning validation concepts, methodologies, and regulatory requirements.
- Experienced in creating and reviewing cleaning validation protocols, reports, risk assessments, and related GMP documentation.
- Understand GMP manufacturing equipment, cleaning processes, and sampling techniques like swab and rinse sampling.
- Familiar with the cleaning validation lifecycle, revalidation tasks, and continuous process improvement initiatives.
- Preferred exposure to health-based exposure limits, MACO, PDE/ADE calculations, and worst-case product selections.
- Ability to work autonomously and supply technical expertise on cleaning validation topics.
- Experience in supporting audits, inspections, remediation activities, or as a Validation Lead or Subject Matter Expert is advantageous.
- Preferred familiarity with sterile manufacturing, biologics, vaccines, active pharmaceutical ingredients, or pharmaceutical production environments.
- Exhibit strong leadership capabilities, communication, and stakeholder engagement skills.
- Proficiency in English communication, both written and spoken.
Company Offerings
- An international workplace embracing over 110 countries represented.
- A culture founded on trust with leadership development opportunities; 70% of leaders started at entry-level roles.
- Comprehensive training with internal academy and access to more than 250 training modules.
- Dynamic workplace environment with regular events such as social gatherings and team-building activities.
- Commitment to sustainability and social responsibility, empowering employees to lead projects with meaningful environmental and social impact through structured programs.
Equal Opportunity Statement
Our organization is dedicated to creating a diverse and inclusive environment, welcoming applicants of all genders, sexual orientations, races, ethnicities, beliefs, ages, marital statuses, disabilities, or other characteristics.
About the Employer
The company is a global, independent technology consultancy serving more than 1,000 clients worldwide with over 7,600 employees across 60+ countries. The business specializes in Information Systems & Digital, Telecom, Life Sciences, and Engineering sectors and fosters talent growth and professional development within a collaborative international community.
Recruitment Process
- Initial brief virtual or phone interview to understand candidate motivations and fit.
- Multiple in-depth interviews with the hiring manager and relevant team members covering experience, skills, job expectations, and company culture.
- Possible technical assessments, role plays, or problem-solving exercises depending on the role.
- Adaptable process tailored to individual candidates ensuring a positive recruitment experience throughout.
Minimum education
Bachelor's Degree
Industry
Management Consulting