Apply on Employer Site

Boehringer Ingelheim · 4 hours ago

Principal Specialist, Validation

Athens, GA

Full-time

Onsite

Senior Level, Lead/Staff

6+ years exp

Boehringer Ingelheim is a global leader in the pharmaceutical industry, dedicated to enhancing the health and wellbeing of people and animals. The Principal Specialist, Validation will manage complex validation project activities, ensuring compliance with GxP regulatory standards, and lead project management efforts for validation activities associated with major site capital projects.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

GMP validationFDA/EU/USDA regulationsProject managementBioengineeringTechnical documentationOffice application softwareLeadershipCommunication skillsConflict management

Required

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)

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

Benefits

Competitive compensation and benefit programs

Programs and groups that ensure your health and wellbeing are looked after

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