Senior Cleaning Validation Engineer – Pharma/Biotech

Validation & Engineering Group; Barceloneta (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Validation & Engineering Group in Puerto Rico is seeking a professional to coordinate cleaning validation activities. Responsibilities include preparing protocols, investigating deviations, and leading the cleaning validation program across various projects.

The ideal candidate should have a Bachelor's or Master's degree in Engineering, with at least 5 years experience in cleaning validation in the pharmaceutical industry. Proficiency in risk management and technical writing is essential for this role.

Qualifications

• Minimum of 5 years of experience in cleaning validation in pharmaceutical and biotechnology industries.
• Proficient in Risk Assessment/Management and cGMP's, OSHA, FDA Regulations.
• Excellent presentation skills and proficient in English/Spanish communication.

Responsibilities

• Coordinate cleaning validation activities and prepare protocols.
• Lead the cleaning validation program and provide technical support.
• Investigate deviations and conduct root cause analysis.

Skills

Cleaning validation

Process improvement

Problem-solving

Time management

Teamwork

Technical writing

Education

Bachelor's or Master's Degree in Engineering

Job description

Validation & Engineering Group,Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical,and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services.

Job Description

Coordinate cleaning validation activities.Prepare and execute protocols and reports for cleaning development andvalidation. Perform investigation of deviations / discrepancies. Oversees and reviews validation area processes.

• Design and develop cleaning procedures for new products and manufacturing equipment.
• Provide technical support to cleaning activities associated with the manufacturing and handling of oral solids drug (OSD) products.
• Also to lead the cleaning validation program and activities.
• Use of cleaning agents and the establishment of sound cleaning practices within new or refurbished manufacturing rooms and sampling suites areas.
• Designs and supports the implementation, i.e. provides training, of cleaning strategies for product transfer projects and product development projects.
• Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non validated or under development cleaning procedures.
• Leads the enhancement of cleaning practices, “clean in place” equipment and introduction.
  Reviews and approves Manufacturing Cleaning Working Instructions and Forms.
• Supports the periodic review of cleaning validation studies.
• Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.
• Issues Change Controls required for the implementation of cleaning procedure changes, as needed.
• Trains manufacturing and QC/QA personnel on cleaning validation documentation.

Qualifications

• Bachelor's or Master's Degreein Engineering.
• Minimum of 5 years of professional experiences in cleaning validation in the pharmaceutical and biotechnology industries (Oral Solid).
• Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
• Proficient time management skills, planning and organization capabilities.
• Proven leadership & teamwork skills, self starter, results oriented and build and maintain 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 (English/Spanish)
• Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry.

Additional Information

Positions availablefor Puerto Rico.

Validation and Engineering Group, Inc.is an Equal Employment Opportunity employer.

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