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Boehringer Ingelheim · 13 hours ago

Validation Engineer III

Athens, GA

Contract

Onsite

Senior Level

6+ years exp

Boehringer Ingelheim is a leading biopharmaceutical company seeking a Validation Engineer III. The role involves drafting and executing validation plans and protocols, serving as a technical resource on project teams, and ensuring compliance with regulatory requirements while supporting engineering and production departments.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsor Likely

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

Utilize industry experience, knowledge and procedures to support Engineering and Production

Performs all company business in accordance with all regulations (e.g. EEO, FDA, etc.) and Company policy and procedures. Demonstrated high ethical and professional standards with all business contacts in order to maintain BIAH's reputation in the community. When violations are noted or observed, they are immediately reported to management

Successfully completes annual training on Compliance Modules as assigned by the Company

Training completion is monitored on monthly basis through KPI reporting to Quality management

Routine qualification execution includes:

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)

Support Maintenance, Engineering and Production Depts. 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

Develops and assists with audit responses and completion of assigned CAPAs by target due dates. Included is the responsibility for making sure Validation areas are 'inspection ready' at all times

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

Qualification

GMP validationRegulatory complianceTechnical writingProject leadershipData analysisCleaning validationBiopharmaceutical productionOffice application softwareCommunication skillsConflict management

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

Company

Boehringer Ingelheim

Glassdoor4.2

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

https://www.boehringer-ingelheim.com/

H1B Sponsorship

Boehringer Ingelheim has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (13)

2024 (4)

2023 (11)

2022 (7)

2021 (17)

2020 (1)