Summary
Responsibilities include execution of Validation and Qualification Protocols related to equipment, computers and facilities with execution and/or supervision of Quality Associates or Electrical Engineers in their execution of Validation Protocols related to packaging processes. Secondary responsibilities include drafting Validation Qualification Protocol Events related to equipment, process and facilities. In addition the position may require drafting Summary Reports for executed protocols under the supervision the Director, Quality Assurance & Compliance. The duties of this position directly impact company compliance to regulatory requirements and customer satisfaction.
Essential Duties and Responsibilities
The following is a list of minimum responsibilities related to this position. Other duties may be assigned.
 Generate and execute, with the support of key stakeholders, validation protocols, qualifications protocols and summaries inclusive of design qualification, installation qualification, operational qualification and performance qualification, as appropriate.
 Performs quality engineering reviews of design documentation for compliance with stated requirements including vendor quality manuals and company quality records
 Ensure all validation activities are up to date in accordance with Good Validation Practices and cGMP.
 Review maintenance requests and work orders to assess impact of work to existing qualified state.
 Support key internal stakeholders on review of new equipment, process, and system requests and assess for validation requirements.
 Participate in customer audits and regulatory inspections.
 Author, review and/or approve SOPs and policies related to validation processes and equipment.
 Draft Confirmation of Changes for appropriate equipment, systems, and processes within guidelines of cGMP and GAMP
 Maintain compliance with cGMP and all competent authority guidelines by regularly reviewing and adhering to SOPs
 Adhere to set safety standards.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
 Bachelor’s Degree and 5+ years of relevant experience OR Associates Degree and 10+ years of relevant experience.
 Thorough knowledge of and proven experience in validation role within the clinical, pharmaceutical, or R&D environment.
 Demonstrated ability to work independently, handle multiple tasks simultaneously, and meet internal and external customer timelines.
 Ability to work in a cross-functional / matrix environment.
 Strong oral and written communication skills.
2 of 2
 Ability to follow and interpret cGMPs, FDA, DEA, OSHA and ISO regulations and guidelines.
 Working knowledge of personal computers and Microsoft Office Products, including Word, Project, and Excel