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Validations Technician/Engineer
Location: Boston, MA

Responsible for developing and implementing protocols to validate equipment, systems, and processes in accordance with appropriate regulatory agency requirements, internal company standards, and current industry practices.

Responsibilities Include:

Assisting with the development of qualification protocols and project plans, re-qualification protocols, and re-validation protocols and for routing the protocols for review and approval by the appropriate departments.

Assisting with the execution of approved protocols and project plans with other departments and/or outside contractors, and consultants as necessary.

Analyzing the qualification results with respect to pre-defined acceptance criteria, determining the acceptability of results, and generating protocol discrepancies as appropriate.

Assisting with the development of final reports that summarize the results of the protocol or project plan and for routing for review and approval by the appropriate departments.

Maintaining the validated state of previously validated equipment, systems, and processes.

Adhering to internal departmental quality systems and procedures that aid in the performance of qualifications, requalifications, and revalidations.

Candidates must possess a Bachelors Degree in Engineering or Scientific discipline and 0-3 years related experience, preferably validation related in the pharmaceutical or biotechnology industry. Excellent organizational, interpersonal, and communication skills - including both oral and written abilities, are essential. Strong computer knowledge including Word, Excel, and Access software is required.