Validation Engineer in Manufacturing, Columbus, OH Full Time Direct Hire
Excellent salary, benefits and Bonus Plan, immediate need!!!!
Responsible for creating and executing process validations to support company goals. Validation activities include development of validation policies and procedures, qualification and re-qualification of facilities, equipment, computer systems, utilities, equipment cleaning, cleanroom qualification, and aseptic processes.
- Develop GxP system lifecycle documentation including validation plans, User Requirements Specifications, Functional Requirements Specifications, testing protocols (IQ/OQ/PQ), user acceptance testing, traceability matrices, final reports, SOPs, change control documentation, and risk assessment (pFMEA) reports as required.
- Assists Validation Manager with the development of company policy regarding validation activities and revalidation requirements, frequency, and responsibilities.
- Lead validation activities on medium to large projects. Ensure the quality, accuracy, and completeness of commissioning, qualification, and validation documentation and deliverables.
- Author risk assessments that identify potential critical process parameters and key operating parameters to prioritize validation activities.
- Creation of validation master plans including process validation and revalidation plans, continued process verification plans, and associated protocol and report templates.
- Work with compounding center management to schedule and plan equipment and process qualification workload to meet approved schedules. Coordinate validation activities with other departments.
- Stay current with industry qualification trends through FDA, ISPE, PDA and bench marked companies.
- Multitask and independently prioritize in a fast-paced environment.
- Ensure existing practices comply with industry standards.
- Support internal and external audits as needed.
- Degree in Engineering, Biochemistry or related field required.
- Minimum of 3-5 years or more (preferred) of validation experience in the medical device, pharmaceutical, or compounded sterile preparation industries. Must include authoring and execution of validation protocols.
Demonstrated understanding of compounded sterile pharmaceuticals in FDA 503B regulated environment preferred.
- Innovative, decisive, results oriented individual contributor with strong problem-solving skills.
- Demonstrated ability to work effectively with all levels of organization.
- Excellent interpersonal, communication, and writing skills, ability to analyze technical issues, define/solve problems, establish project plans, statistically evaluate solutions, and draw valid conclusions.
- Demonstrated results managing many projects concurrently.
- Experience in interaction with regulatory bodies (audits) and development of audit responses preferred.
- Experience in aseptic processing preferred.
- Very familiar with FDA, GMP, and ISO standards.
- Must be proficient in Microsoft Word, Project, Excel, and Outlook.
Must be a US Citizen to apply. Several face to face interviews will be required so local candidates will be considered first. Must be able to pass a background check and drug test.
Apply today or email email@example.com for quicker consideration