Job Description

Description:

Engineer or Senior Engineer, Quality

Dual-Level posting, position level to be awarded at the discretion of the hiring manager. 

 

Engineer, Quality Description\:

The Quality Engineer delivers validation of biopharmaceutical manufacturing equipment, utilities, computer systems and laboratory instruments and ensures the Engineering and Technology (E&T) department maintains and continuously improves its state of GMP compliance.  They will be responsible for performing qualification and validation activities in a multi-product biotech manufacturing facility and owning records (deviations, CAPAs, Change Control) within the quality systems. The BIFI Quality Engineer will develop risk assessments, validation plans, protocols, and reports that support the qualification and validation of systems. This individual will be responsible for independently developing moderately complex protocols for medium size validation projects using a risk-based approach that meets current regulatory requirements and industry practices.  They will execute small sized projects, review and interpret data for accuracy of system performance for completed validations/revalidations and prepare final report packages by analyzing and summarizing the data. The Validation Engineer will provide technical support and guidance to other project team members in protocol preparation, execution and data interpretation.  Develop site-specific validation procedures and shared practices as applicable in accordance with the requirements set forth in the governing quality standards in partnership with corporate procedures. Additionally, the BIFI Quality engineer will own Quality System records, investigate deviations, write investigation reports, and create and own CAPAs and change controls. This individual will represent the manufacturing plants systems in internal, customer and regulatory audits by preparing and presenting the documentation associated with GMP Systems and processes.

 

Senior Engineer, Quality Description\:
The Quality Engineer delivers validation of biopharmaceutical manufacturing equipment, utilities, computer systems and laboratory instruments and ensures the Engineering and Technology (E&T) department maintains and continuously improves its state of GMP compliance.  They will be responsible for performing qualification and validation activities in a multi-product biotech manufacturing facility and owning records (deviations, CAPAs, Change Control) within the quality systems. 

The Quality Engineer will develop risk assessments, validation plans, protocols, and reports that support the qualification and validation of systems. This individual will be responsible for independently developing moderately to highly complex protocols for medium to large size validation projects using a risk based approach that meets current regulatory requirements and industry practices.  They will execute small to medium sized projects, review and interpret data for accuracy of system performance for completed validations/revalidations, and prepare final report packages by analyzing and summarizing the data.  

The Validation Engineer will provide technical support and guidance to other project team members in protocol preparation, execution and data interpretation.  Develop site-specific validation procedures and shared practices as applicable in accordance with the requirements set forth in the governing quality standards in partnership with corporate procedures. They will supervise contract validation staff who are providing validation support.

Additionally, the Quality engineer will own Quality System records, investigate deviations, write investigation reports, and create and own CAPAs and change controls. This individual will represent the manufacturing plants systems in internal, customer and regulatory audits by preparing, presenting and defending the documentation associated with GMP Systems and processes.

 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.

 

Engineer, Quality Duties & Responsibilities\:

• Lead/manage medium size validation (Equipment/System) projects\:
  • Provide risk assessments for new systems and changes to existing systems.
  • Write complex validation plans, protocols and reports.   
  • Draft estimates of validation resource requirements.
• Owning Quality Systems Records\:
  • Create, 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, TrackWise) 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 CAPAs.
• Preparing material and presenting directly to internal/external regulatory and customer auditors.
• Developing, writing, editing materials such as; Standard Operating Procedures (SOP), Business Practices, forms, checklists, and related technical and business process documentation. Documents include SOPs for operation and maintenance of manufacturing equipment, facilities and automation systems.
• Generating quality system metrics.

 

Senior Engineer, Quality 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 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 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.
• Compliance
  • Acting as the single point of contact for E&T on all customer and external agency audits.  
  • 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 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.

 

Engineer, Quality Requirements\:

• Bachelors Degree in science or engineering with 5 years of related field experience, or Masters Degree in engineering with 3 years of relevant cGMP biopharmaceutical manufacturing environment experience in either validation, quality systems, operations, engineering or any combination thereof.
• 2 years recent experience with validation to qualify typical bulk manufacturing equipment and/or computer systems at a multi-product biopharmaceutical manufacturing facility.
• 1-3 years’ experience leading employees and/or projects.
• Preferred knowledge of Validation Lifecycle Approach (e.g. ASTM E2500, GAMP) and review/approve lifecycle documentation (URS, FRS, FAT/SAT, Commissioning Protocols, etc).
• Preferred validation experience using risk based approach (FMEA, PHA, etc).
• Working knowledge of GMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements.
• Excellent technical writing and verbal communication skills.
• 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 situations 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.
• Experience with SAP, TrackWise, Documentum, Maximo, OSI Pi, and SharePoint.
• Advanced knowledge of Microsoft Excel.
• Good knowledge and skills in biopharmaceutical and process engineering.
• Participation on technical projects with an interdisciplinary project team.
• Experience in one or more validation disciplines (Equipment/System Qualification, Utility, Laboratory, Automation and/or Computer Systems).
• Understanding of validation concepts for biopharmaceutical manufacturing process, instrumentation and utility equipment.
• Experience with investigations into manufacturing deviations and determination of product impact potential, root cause, and corrective actions.
• Preferred experience with thermal mapping equipment (Ellab a plus) in validating, Autoclaves, Tanks, and other temperature controlled units.

 

Senior Engineer, Quality Requirements\: 

• B.S. in science or engineering. MBA or M.S. in science or engineering is preferred.
• 1 to 3 years’ experience lading employees and projects.
• 5+ years (Sr. Engineer with minimum of 10 years’ experience) of relevant cGMP biopharmaceutical manufacturing environment experience in either validation, quality systems, operations, engineering or any combination thereof.
• Of the experience, 2 years (5 years for Sr. Engineer) 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 2 or more validation disciplines (Equipment/System Qualification, Utility, Laboratory, Automation and/or computer Systems) with proficient technical knowledge
• 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.
• Ability to read/interpret engineering drawings and design documents.
• Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
• Experienced in Microsoft Office Suite, SAP, Documentum, Maximo, OSI Pi, and SharePoint.

 

Senior Engineer, Quality 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.

 

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
• This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click   and join us in our effort to make more health.

  Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.

   

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