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Boehringer Ingelheim · 6 hours ago

Validation Engineer III

Athens, GA

Full-time

Onsite

Senior Level

6+ years exp

Boehringer Ingelheim is a leading company in the biopharmaceutical industry, and they are seeking a Validation Engineer III to oversee complex validation plans and ensure compliance with regulatory requirements. The role involves training personnel, providing technical support, and serving as a lead representative on project teams to facilitate successful project completions and product launches.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

U.S. Citizen Only

Responsibilities

Independent drafting and execution of complex validation plans, protocols, and test strategies to ensure compliance and expedited release of critical site equipment

Serve on assigned internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality related issues and/or support continuous improvement

Train personnel in quality and validation principals

Support, Engineering and departments in the selection, review, acquisition, and upgrade of systems and production equipment

Provide technical support in developing user and functional requirements specifications, URS, RA FRS and DQ for systems and equipment

Serve as Lead Validation representative on assigned project teams and communicate new requirements/perform training with Validation team to assure all timelines are met resulting in successful project completion and new product launches

Utilize industry experience and knowledge to support Production and Engineering

Share quality philosophies throughout Operations

Perform routine qualification execution including: Equipment, facilities, utilities, computer systems qualification for complex biopharmaceutical production equipment

Room Qualification and Smoke studies in grade A pharmaceutical facilities Media fill qualifications oversight and support

Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers and warehouse areas

Extensive experience with Ellab data loggers and software

Extensive technical writing experience to independently write and execute protocols and complete final reports (minimal oversight from validation reviewer)

Comprehensive knowledge and understanding of cleaning validation concepts and principles

Comprehensive knowledge and understanding pharma grade utilities (water HVAC, gases)

Develops and assists with audit responses and completion of assigned CAPAs by target due dates

Execute all actions required to support Change Control, Deviation and CAPA on-time closure

Qualification

GMP validationRegulatory complianceTechnical writingData analysisCleaning validationBiopharmaceutical productionProject leadershipOffice software proficiencyConflict managementCommunication skills

Required

6 years GMP validation or similar experience in a GMP manufacturing or similar production environment

Minimum of 10 years GMP validation experience in a GMP or regulated manufacturing or similar environment in lieu of a degrees

Experience must be inclusive of at least 3 years leading projects

Ability to plan, schedule, organize, prioritize and coordinate project activities

Ability to function in a leadership role and within cross function teams

Ability to analyze validation and production data to assess compliance with GMP requirements and/or troubleshoot compliance problems

Excellent written and verbal communication skills

Excellence in comprehension/application of FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles

Strong theoretical and practical knowledge of regulated processes and one technical discipline, such as biology to apply knowledge or experience to assigned tasks

Ability to make decisions regarding the acceptability of product based on documentation provided

Demonstrated ability to work with diverse groups of people and conflict management

Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook, PowerPoint)

Bachelors, preferably in a science or engineering related field

Work Authorization: US Citizen

Preferred

1 years

Company

Boehringer Ingelheim

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Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.

Founded in 1885

Ingelheim Am Rhein, Rheinland-Pfalz, DEU

10001+ employees