Senior Specialist / Principal Specialist, Validation

Boehringer Ingelheim; Athens (GA); On-site; USD 110,000 - 165,000; Full time

Job summary

Boehringer Ingelheim USA in Georgia seeks a Senior Specialist, Validation to manage high-level GMP validation activities at the BIAH site, ensuring compliance with the Validation Master Plan and regulatory requirements. You will coordinate cross-functional teams, schedule testing, and review critical documents to support complex validation projects.

The role requires strong project leadership, regulatory know-how, and a track record of delivering validated systems, equipment, and processes that

Qualifications

• Bachelor's degree in a scientific/engineering discipline is required.
• Minimum 6 years of GMP validation experience; more senior level with leadership is preferred.
• Experience with FDA/EU/USDA regulatory expectations is highly desirable.

Responsibilities

• Lead complex GMP validation projects from concept to process validation.
• Oversee validation documentation, CAPA assessment and change controls.
• Coordinate with QA, QC, engineering and maintenance for validation activities.

Skills

Project management

Leadership

Regulatory compliance

Education

Bachelor degree in a relevant discipline

GMP validation experience (6+ years)

Tools

MS Office

Job description

SENIOR SPECIALIST DUTIES & RESPONSIBILITIES

Responsible for managing higher level, more complex GMP validation project activities at the BIAH sites from concept through process validation as outlined by the Site Validation Master Plan (VMP) and Corporate Policies and Procedures. Maintain site validation database and document systems, support feasibility studies, equipment review, selection, acquisition and upgrade. Develop and maintain higher level departmental and site standard operating procedures (SOP) and training operations on quality principles. Support and facilitate strategic direction of validation philosophies, improve overall validation system and process flow incorporating into the Site VMP. Provide oversight and document review for smaller validation projects and routine Validation Maintenance deliverables. Support Engineering and Maintenance activities associated with Quality Systems. Preparation of validation protocols, coordinating, scheduling and test execution, for areas including but not limited to Biological Production, QA, QC, Sterile Filling, Packaging & Labeling and Logistics. Provide peer review for validation protocols and reports. Maintain calibration status of validation test 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 Operations personnel in quality and validation principals. Support 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, FRS, for systems and equipment. Assist with internal, regulatory or Corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents. Assist 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. Support Change Control and CAPA activities. Performs all company business in accordance with all regulations (e.g. USDA, etc.) and Company policy and procedures. Demonstrated high ethical and professional standards with all business contacts to maintain BIAH excellent reputation in the community. When violations are noted or observed, they are immediately reported to management.

Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Specialist manages all phases of higher level, more complex validation project activities at the BIAH location from concept through process validation ensuring GMP regulatory compliance continues as outlined in the Site Validation Master Plan (VMP) and Corporate Policies and Procedures. This includes, but is not limited to scheduling, conducting, and verifying facilities, utilities, equipment, systems and processes meet specifications and requirements are suitable for their intended purposes. Lead project management efforts for validation activities associated with major site capital projects. This includes, but is not limited to, contractor oversight, document review, deviation management and CAPA assessment, as applicable. Provide department review/approval to routine validation documents. This individual will be a resource for validation information within the Quality and Compliance unit. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

The Principal Specialist, Validation

The Principal Specialist, Validation manages all phases of higher level, more complex validation project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAH's Validation Master Plan (MVP) and Corporate Policies and Procedures. This position is critical to the compliance effort and is responsible for assuring compliance of validated systems, process, equipment to current cGMP, FDA, EU, USDA, BIAH and BI corporate requirements. This includes, but is not limited to scheduling resources, conducting testing, and verifying facilities, utilities, equipment, systems and processes meet specifications and requirements and are suitable for their intended purposes.

The Principal Specialist, Validation will lead project management efforts for validation activities associated with major site capital projects as well as oversee small department projects and provide technical support to team members. This includes, but is not limited to, contractor oversight, document review, deviation management and CAPA assessment, as applicable. Provide department review/approval to routine validation documents. This position serves as a subject matter expert for internal and external department/site and global projects.

PRINCIPAL DUTIES & RESPONSIBILITIES

• Responsible for managing higher level, more complex GMP validation project activities at the BIAH US locations from concept through process validation as outlined by BIAH's Validation Master Plan (VMP) and Corporate Policies and Procedures
• Maintains site validation database and document systems, supports feasibility studies, equipment review, selection, acquisition and upgrade
• Develops and maintains higher level departmental and site standard operating procedures (SOP) and training on quality principles
• Promotes staff development and growth, performs training to staff and other departments
• Leads and actively supports strategic direction of validation philosophies, improve overall validation system and process flow incorporating into BIAH VMP
• Provides oversight and document review for smaller validation projects and routine Validation Maintenance deliverables
• Develops and Maintains local standard operating procedures to follow all FDA/EU/USDA regulations, as well as Corporate procedures
• Serves 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
• Trains personnel in quality and validation principals
• Supports Engineering and departments in the selection, review, acquisition, and upgrade of systems and production equipment
• Provides technical support in developing user and functional requirements specifications, URS, RA FRS and DQ for systems and equipment
• Participates with internal, regulatory or Corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents
• Develops and assists with audit responses and completion of assigned CAPAs by target due dates
• Responsible for ensuring Validation areas are "inspection ready" at all times
• Supports Change Control, Deviation and CAPA activities
• 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 to maintain BIAH's reputation in the community
• Immediately reports noted/observed violations to management

PRINCIPAL REQUIREMENT

Bachelor Degree in a relevant scientific, bioengineering or relevant discipline Six (6) years GMP validation or similar experience in a GMP manufacturing or similar production environment Minimum of ten (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 three (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).

Eligibility Requirements:

Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com