Validation Engineer

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning and 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.

Job required Qualification:

• Bachelor of Science degree, Engineering, or Equivalent training and experience.
• More than 5 years of experience in a regulated environment.
• 3 years of experience authorizing procedural and commercial marketing documents.
• More than 3 years of experience with clean rooms, aseptic suites, single-use technology, bioreactors, and cell culture.
• Experience in mechanic and Industrial engineering
• Strong working knowledge of pharmaceutical industry regulations (GMP, GDP, ICH, etc.)
• Strong understanding and working knowledge of project lifecycle, entrepreneurial mindset, and excellent written and verbal communication skills.
• Strong relationship management, leadership, and organizational skills.
• Strong working knowledge in Microsoft suites, and Smartsheet.

Job responsibilities and Duties:

• Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations.
• Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products (and R&D products as applicable).
• Develop and execute validation/verification protocols for all commercial and R&D manufacturing, processing, and packaging equipment.
• Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.
• Gather photocopies and compile relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw material certificates of analysis.
• Investigate and resolve deviations/exceptions from the predefined acceptance criteria.
• Draw conclusions from data, observations, deviation/exception, and investigation as to whether the process is considered valid.
• Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.
• Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.
• Ensure protocols, verifications, validation plans, and summary reports generated during validation/ qualification activities are stored according to the procedure.
• Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company. Work proactively to maintain the highest level of compliance in all areas. Gather current knowledge from QA/QC, regulatory, periodicals, and/or appropriate training programs.
• Interact and coordinate compliance efforts with other departments including, but not limited to, Operations, Engineering, QA, laboratories (QC and R&D), and R&D to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet departmental and Company objectives.