Validation Engineer

Job Description

A pharmaceutical company in the Clayton, NC area is looking for Validation Engineers to join their growing team. Areas where projects will be executed are in facility systems, aseptic formulation and filling, device assembly and packaging, IT systems, and QC.

Responsibilities: -Generate and/or update all validation related documents according to procedures (ie. validation planning, specifications, risk assessments, protocols, reports). -Generate and execute all documentation for DQ, IQ, OQ, and PV activities. -Responsible for tracking all project related documentation related to validation including protocols, specifications, and impacted SOPs. -Generate and act as owner of the change control. -Utilize eTIMS software to generate validation documents. -Lead effort for generating documentation related to decommissioning activities

Skills and Requirements

-Bachelor's degree in Engineering or related field -3+ years of validation experience in a cGMP environment, supporting equipment qualification and facilities commissioning activities -Strong knowledge of validation principles, including IQ/OQ/PQ protocols. -Experience with Process/Equipment/Computer System Validation -Preference or experience with packaging equipment and IT/automation projects

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].