Boehringer Ingelheim is currently hiring for two Senior Validation Engineers at our Fremont, CA facility. The successful candidates will join the US-based arm of the BI’s global Biopharmaceuticals Engineering and Technology (E&T) team, responsible for Qualification, Validation and Technical Compliance. The Sr. Validation Engineer will serve as the validation manager for a growing portfolio of projects in support of the Fremont site expansion. Areas in focus include bulk manufacturing, cell culture, purification, filling, secondary packaging, facilities, utilities and computer systems. They will work closely with owners and subject matter experts from quality, manufacturing, engineering and IT. Additionally, they will help build and maintain the state of compliance in E&T as we move multiple late stage products toward commercial manufacturing approval by regulatory agencies.
The position reports directly to the head of Qualification and Technical Compliance. They interface daily with other Sr. level Validation Engineers, regularly with Global Biopharma colleagues, and mentor associate level staff. They present directly to auditors/inspectors, build qualification and validation standards and manage both internal and external providers of validation services on projects. The position requires expertise in qualification concepts and in-depth experience in qualification of biopharmaceutical manufacturing computerized system, equipment, utilities and/or facilities. Join the growing Qualification and Technical Compliance team as we expand the local site and move toward commercialization!
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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
Lead/Manage validation projects including:
* Provide risk assessment for new systems and changes to existing systems
* Write validation plans, protocols and reports
Execute and provide reviews of validation protocols and validation periodic monitoring
* Lead or participate in project team including the supervision of validation contractors
* Provides estimates of validation resource requirements.
Owning Quality Systems Records
* Create and own and manage life cycle of deviations, corrective actions and change controls for GMP equipment, facilities and automation systems
* Operate within the relevant quality computer systems (ex. SAP) ensuring implementation in line with quality and timeliness objectives
* Working closely with Engineering, Quality, Process Development, Validation, and Manufacturing to investigate and resolve deviations including leading investigation teams in order to determine root cause, product impact, and appropriates corrective and preventive actions
* Acting as the single point of contact for E&T on all customer and external agency audits. Preparing material for and presenting directly to internal and external regulatory and customer auditors
* Monitoring and mitigating compliance risks for the E&T department.
* Provide responses to audit observations and own audit related CAPA commitments
Improving the compliance infrastructure including creation of presentations and audit readiness material
* Developing, writing, editing, and formatting materials such as Standard Operating Procedures (SOP), Business Practices, forms, checklists, and related technical and business process documentation fro the engineering and technology department. Documents include SOPs for operation and maintenance of MP equipment, facilities and automation systems.
* Generating and reporting on quality system metrics for the E&T department.
* Bachelors’ Degree in science or engineering, from an accredited university or college. Advanced degree, MBA or Masters in science or engineering is preferred.
* Minimum of 10 years’ experience of relevant cGMP biopharmaceutical manufacturing environment experience in either engineering validation, quality systems, operations, engineering or any combination thereof. Of the experience, at least 5 years must be recent experience with validation to qualify typical bulk manufacturing equipment and/or computer systems at a multi-product biopharmaceutical manufacturing facility.
* Experience in two or more validation disciplines (Equipment/System Qualification, Utility, Laboratory, Automation and/or computer Systems) with proficient technical knowledge
* 1 - 3 years’ experience leading employees and projects.
* Knowledge of Validation Lifecycle Approach (e.g. ASTM E2500, GAMP) and review/approve lifecycle documentation (URS, FRS, FAT/SAT, Commissioning Protocols, etc).
* Understanding of validation concepts for biopharmaceutical manufacturing process, instrumentation and utility equipment.
* Working knowledge of GMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements
* Proven skill in use of thermal mapping equipment (GE/Kaye Validator 2000 a plus) in validating, Autoclaves,Tanks, and other temperature controlled units
* Validation experience using risk based approach (FMEA, PHA, etc)
* Experience with investigations into manufacturing deviations and determination of product impact potential, root cause, and corrective actions
* Experience interacting with, or creating material for, representatives of regulatory agencies and executive level staff
* Excellent technical writing and verbal communication skills
* Ability to read/interpret engineering drawings and design documents
* Ability to work as part of a high performing team and collaborate effectively with staff at all levels. * Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
* Demonstrated ability to manage multiple activities while maintaining a high level of organization
* Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
* Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers.
* Experienced in Microsoft Office Suite
Preferred Qualifications - Experience with SAP, Documentum, Maximo, OSI Pi, and SharePoint; Advanced knowledge of Microsoft Excel
Desired Experience, Skills and Abilities:
* Good knowledge and skills in biopharmaceutical and process engineering.
* Leading or managing of technical projects with an interdisciplinary project team from planning to realization and start up.
* 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
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Vetmedica Inc. and Boehringer Ingelheim Fremont Inc., is an equal opportunity employer. M/F/D/V
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.