Validation Engineer II

Job description

The Validation Engineer II will develop and execute validation plans, protocols and reports that support the business needs of the company. The position will oversee and support the qualification and validation of the pharmaceutical manufacturing processes and ensure that the facility, systems and processes perform according to internal specifications, comply with current GMPs and are maintained in a validated state. This position will report into the Manager, Validation. Essential Duties and Responsibilities: Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. - The incumbent will act as a Subject Matter Expert (SME) for a designated discipline/s. Focusing on Packaging, Equipment and Facilities and/or Cleaning Validation, the incumbent will develop and execute validation protocols associated with the installation, operation and performance qualification and requalification of equipment, utilities and processes used in the manufacture of aseptically produced parenteral pharmaceuticals, including lyophilized solutions. - The SME will provide technical expertise during design, evaluation and procureme...