Sr. Engineer – Process Development (CQV)

Job Title: Sr. Engineer – Process Development (CQV)Location: Ohio — OnsiteEmployment Type: W2 ContractDuration: 6+ MonthsSalary/Rate$45–$50 per hour on W2This represents a good-faith estimate of the anticipated compensation range for this position. Actual compensation may vary based on qualifications, experience, location, and other lawful job-related factors.BenefitsThis is a contract role, and employer-provided benefits are not applicable.Job SummaryWe are seeking a Sr. Engineer – Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final Drug Product (FDP) manufacturing environment. This role will lead commissioning, qualification, and validation activities for new and existing equipment and processes while supporting compliance with applicable FDA requirements, GMP expectations, and internal quality standards.ResponsibilitiesLead commissioning, qualification, and validation (CQV) activities for automated and semi-automated combination product equipment, including assembly, labeling, and packaging systems.Author, execute, and support documentation for validation protocols, including IQ, OQ, and PQ activities.Maintain and update master validation plans in alignment with applicable regulatory requirements and internal quality standards.Serve as a technical subject matter expert for automated systems and combination product validation.Collaborate with Engineering, Quality, Manufacturing, and other cross-functional teams to implement and maintain validated systems supporting continuous production operations.Support onsite and off-shift validation activities, including occasional weekend work, based on project and production requirements.Ensure validation documentation and practices meet applicable GMP requirements for Final Drug Product manufacturing.Required QualificationsSignificant experience with Commissioning, Qualification, and Validation (CQV) activities in GMP-regulated manufacturing environments.Hands-on experience with automated or semi-automated manufacturing equipment and assembly, labeling, or packaging processes.Strong experience authoring and executing IQ/OQ/PQ validation protocols.Experience supporting validation activities for combination products.Working knowledge of applicable FDA regulations, GMP requirements, and quality compliance practices.Ability to work onsite in Ohio and support flexible schedules, including occasional off-shift or weekend validation activities, when required.Preferred QualificationsExperience with Kneat or other electronic validation lifecycle management systems.Experience supporting validation within Final Drug Product manufacturing operations.Work RequirementsThis is an onsite position in Ohio.The anticipated start date is September 8, 2026.The role may require occasional work outside standard business hours, including off-shift and weekend validation activities, based on operational and project needs.Employees and contractors must comply with applicable site safety, security, quality, GMP, and other workplace requirements.Employment decisions will be based on legitimate job-related qualifications and business needs in accordance with applicable federal, state, and local laws.Equal Opportunity EmployerWe are an equal opportunity employer and consider qualified applicants without regard to legally protected characteristics under applicable federal, state, and local law. Reasonable accommodations may be available for qualified individuals with disabilities and for sincerely held religious practices, as required by applicable law.ApplicationQualified candidates are encouraged to apply with an up-to-date resume highlighting relevant CQV, GMP manufacturing, combination product, automation, and validation experience.