Senior Specialist / Principal Specialist, Validation

Boehringer Ingelheim GmbH; Spring Valley Estates (GA); On-site; USD 100,000 - 130,000; Full time

Job summary

Boehringer Ingelheim US is seeking a Senior Specialist, Validation to lead GMP validation programs from concept through process validation at the BIAH site, ensuring regulatory compliance and alignment with the Validation Master Plan.

The role oversees SOP development, CAPA assessment, audits, and coordination of cross-functional teams, with a focus on ensuring inspection readiness and continuous improvement.

Qualifications

• Bachelor Degree in a relevant scientific, bioengineering or related discipline.
• Minimum GMP validation experience with leading projects and cross-functional teams.
• Ability to plan, schedule, organize and coordinate validation activities.
• Excellent written and verbal communication skills.

Responsibilities

• Lead high-level GMP validation projects from concept through process validation.
• Maintain validation databases and document systems; support feasibility studies.
• Develop SOPs and training on quality principles.
• Oversee audits, CAPA assessments, change controls and deviations.
• Provide technical support for URS/FDV/DS for systems and equipment.

Skills

GMP validation leadership

Project management

Quality systems

SOP development

CAPA & deviation handling

Audit support

Staff training

Document review

Education

Bachelor Degree in a relevant scientific discipline

Tools

MS Word

MS Excel

MS Outlook

PowerPoint

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 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.