Validation Engineer - II

At Proclinical, we are seeking an individual to fill the role of Validation Engineer - II, based Lebanon, NH. This position will work on validation activities where in-depth analysis, authoring protocols, teamwork and flexibility are required. The person in this role will also be responsible for validation activities in several areas of pharmaceutical manufacturing including, but not limited to, DQ, IQ, OQ, PQ, requalification, cleaning, sterilization and utilities.

Responsibilities

• Execute validation protocol, data analysis and final reports preparation for utilities, equipment and instrumentation.
• Maintain effective communication and ensure alignment in coordination with appropriate teams.
• Support facility certification for new Manufacturing and Quality Control facilities as needed as well as the continued operation of such facilities.
• Ensure systems and processes are validated.
• Participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations.
• Complete accurate and timely assessments associated with change control activities.
• Ensure change control activities for systems are completed.
• Support validation of new and existing equipment, processes and instrumentation as needed.
• Write and review protocols, summary reports and other documentation associated with validations.
• Coordinate validation activities internally as well as with external vendors as needed.
• Represent the validation department on cross-functional teams.
• Assist in the training of and/or direct the efforts of less experienced Validation Engineers and Validation Technicians.

Skills And Qualifications

• BA or equivalent and 3+ years of validation experience in the pharmaceutical/biotech industry.
• Experience preparing protocols, executing data analysis, and report writing.
• Ability to demonstrate broad understanding of concepts of validation, change control processes, root cause analysis techniques and cGMP documentation practices.
• Knowledge of all industry standards pertaining to validation.
• Technical requirements for validation and of biopharmaceutical equipment, facilities and/or instrumentation.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Chris Frank at +1 267 405 6996 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.