Sr. Specialist/Principal Specialist, Validation

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, diversity and inclusion, 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.

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.

Requirements for a Principal Specialist - Validation

• 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).

Requirements for a Sr. Specialist Validation

• A BS degree from an accredited institution in Engineering, Bioengineering or relevant discipline, and a minimum of four (4) years of validation experience or similar experience in a GMP manufacturing or similar production environment.

• • In lieu of degree, a minimum of eight (8) years of validation experience or manufacturing experience in a GMP or similar regulated manufacturing environment.
• • Experience must be inclusive of two (2) years in leading projects or teams.
• • One to two (1-2) years of Project Management experience.
• • NOTE: Relevant BIAH experience may be weighted more significantly.
• • Exceptional logical skills with excellence in written and verbal communication skills.
• • Functional knowledge of validation of biopharmaceutical processes, equipment, utilities, facilities, cleaning validation, and USDA and FDA/EU regulations.
• • Excellence in comprehension/application of USDA and FDA/EU regulatory requirements for validation/qualification of equipment/process/cleaning of regulated biological articles.
• • Technical knowledge to provide assistance, as needed, for manufacturing, engineering, and validation troubleshooting.
• • Strong theoretical and practical knowledge of regulated processes and technical discipline, to apply knowledge or experience to assigned tasks.
• • Ability to make decisions with minimal supervision regarding the requirements for industry standard qualification of equipment used in biological production.
• • Ability to plan, schedule, organize, prioritize and coordinate project activities.
• • Ability to use typical validation / data acquisition equipment.
• • Excellent attention to detail.
• • This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source, TrackWise and other relevant electronic applications.
• • Understanding of GMP´s, compliance requirements, Outlines of Production, and 9 CFR knowledge to assess product, procedures, recommend improvements and make correct decisions.
• • Ability to effectively communicate technical information in a clear, concise manner within a GMP-regulated environment.
• • Flexibility to work off-hours and weekends as required to support manufacturing plant projects.
• • Physical Demands / Surroundings: May be required to lift 50 lbs and wear required personal protective gear.
• • Temperaments/Mental Requirements: May be required to work in hot and cold environments. Able to use focused thinking and deductive reasoning in stressful environments.

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.

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All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.