Validation Engineer / Senior Validation Engineer

The Validation Engineer / Senior Validation Engineer will be responsible for activities related to the lifecycle of qualified equipment and systems, ensuring validation and calibration activities meet requirements to maintain regulatory compliance and desired instrument, equipment and system performance. The position will require hands-on equipment calibration and validation activities, extensive use of electronic document and quality management systems, and the supervision of validation/calibration contract service providers.

Responsibilities:

-Author and review (internal and out-sourced) validation protocols and reports using electronic document management systems and procedures

-Employ good documentation practices (GDP) when creating, recording and reviewing validation and calibration data

-Work closely with Process and Analytical Development, Quality, Facilities, and Production to plan and execute validations and calibrations, and to investigate and resolve deviations associated with equipment validations and calibrations

-Supervise/escort contract service providers engaged to execute qualification and calibration activities (including the development of any vendor-created or provided documentation)

-Perform validation and calibration activities, including within cleanroom environments

-Own and process change controls and CAPAs related to validation and calibration activities

-Assist in internal and external audits and in providing responses to audit observations related to calibration and validation responsibilities

-Monitor and trend validation and calibration data

-Author and assist in the development, writing, and revising of validation and calibration related Policies, Standard Operating Procedures (SOP), forms, specifications and other required documents

-Assess and evaluate various types of laboratory and production equipment for proper validation and calibration requirements

-Maintain validation and calibration standards

-Maintain knowledge of current industry standards and regulatory requirements related to validation and calibration

Qualification Requirements:

Three or more years of relevant experience in a regulated biopharma manufacturing or laboratory environment, with exhibited knowledge and understanding of commissioning, qualification and calibration, including the related document development and document management responsibilities

-Ability to communicate efficiently and effectively with peers, senior management, key stakeholders and outside contract service providers/vendors

-Ability to present data and positions clearly and convincingly, to internal and external parities and stakeholders

-Experience participating in regulatory inspections, internal and external audits, and representing internal practices, polices and procedures related to an area of subject matter expertise, preferably in validation and calibration

-Proven collaboration skills, learning agility, conceptual and strategic thinking, passion for results, and ability to navigate ambiguity

Technical Skills and Knowledge:

-Calibration and validation experience associated with process equipment, utilities, and laboratory equipment

-Advanced proficiency in navigating and using electronic document and quality management systems

-Proven skill in performing validation tasks for various types of equipment and instrumentation used in research and manufacturing

-Experience with deviations and investigations into validation/calibration failures and determination of product impact potential, root cause, and corrective actions

-Excellent technical writing and verbal communications skills

-Ability to read/interpret and comprehend engineering drawings, technical information and design documents

-Ability to work as part of a high performing team and collaborate effectively with staff at all levels

-Demonstrated ability to execute multiple activities while maintaining a high level of organization

-Demonstrated 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 company goals