Job Details

Validation Engineer Cleaning Validation

Company name
Bristol-Myers Squibb Company

Location
Devens, MA

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Validation Engineer - Cleaning Validation

in

Devens

Massachusetts

Title:

Validation Engineer - Cleaning Validation

Location:

NA-US-MA-Devens

Job Number:

1703528

At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.

Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.

We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.

The Validation Engineer leads validation efforts associated with the operation of all GMP manufacturing systems. Primary areas of focus include validation of automated systems, cleaning validation, steam in place validation, and periodic assessment / revalidation activities.

· Responsible for implementing the design, implementation and maintenance of a robust cleaning validation lifecycle for process equipment and systems, that includes a bench-scale cleaning program, an efficient cleaning validation philosophy, a cleaning monitoring program, and a cleaning verification changeover program for a fully automated, multi-product biologics manufacturing facility.

· Establish and implement the cleaning validation philosophies and master plans required to drive the cleaning validation lifecycle.

· Responsibilities include oversight of cleaning validation lifecycle maintenance that includes establishment of validation document hierarchy, tracking execution work arising from change controls, shutdown/changeover management related to validation, and management of the revalidation and cleaning monitoring programs.

· Responsible for regulatory inspection readiness and guidance to ensure cleaning validation and cleaning verification changeover philosophies are well understood.

· Manage multiple projects.

· Work collaboratively with peers within the Validation Execution function, Manufacturing Systems, Information Technology, Manufacturing, Manufacturing Engineering and Quality

· Effectively manage workload to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.

· Ensure alignment with BMS directives and industry guidelines on cleaning validation and quality engineering.

· Leads and/or executes validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing validation lifecycle programs. This individual works at the highest level and collaborates with Quality Assurance, to establish appropriate, risk-based validation methodologies.

· Provides validation subject matter expertise (SME) and contributes to multi-function teams, advises operations on cleaning validation matters.

· Supports internal compliance and/or efficiency improvement efforts within department for more complex processes.

Qualifications:

QUALIFICATIONS:

· Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experience

· A minimum of 6 years relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.

· Experience with process equipment and system qualification, steaming/sterilization qualification, cleaning validation, and multi-product changeover requirements.

· Experience in designing cleaning program elements, steaming/sterilization program elements, bench-scale studies to support cleaning and implementation of supporting quality systems required to manage the cleaning cycles and changeover program of a fully automated, multi-product, biologics manufacturing facility.

· Experience in establishing site and program validation strategies that are aligned with current industry mindsets.

· Understanding of the US and ex-US regulatory requirements for licensure of a multi-product biopharmaceutical facility.

· Understanding of lean principles and establishment of effective process metrics is preferred.

· Project management, communication, and technical writing skills are required.

· Possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.

· Working knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the technical acumen to work and manage within a regulatory environment.

· Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics manufacturing.

· Ability to develop and apply new and innovative approaches to projects and processes.

· Must be able to influence others.

· Demonstrated emotional intelligence required to inspire and influence the behaviors and performance of others, as well as for conflict management.

· The flexibility required to constructively lead and encourage peers and team members to drive results in a changing environment.

Together, we make a difference. Bristol-Myers Squibb is one of the world’s BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that’s a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference. If you want to join us, apply now at www.bms.com/careers

Bristol-Myers Squibb is an equal opportunity employer - Minorities/Females/Protected Veterans/Disabled

Job: Validation

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Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com

Company Profile
Bristol-Myers Squibb is a global BioPharma company firmly focused on its Mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

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