Johnson Johnson is seeking a highly skilled Director, Commissioning Qualification in the Commissioning Qualification field. This position will be located in North Carolina.

At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

For more than 130 years, diversity, equity inclusion (DEI) has been a part of our cultural fabric at Johnson Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson Johnson, we all belong.

Apply now to join our ambitious team and make a meaningful impact on the world through our outstanding engineering opportunities at Johnson Johnson.

In this role as Director, Commissioning Qualification, you will have the exceptional opportunity to lead the CQ activities and Engineering Document Control in large capital projects, from Strategy to Business Readiness, including aspects of project planning, resource management, execution logistics, close-out, document management, VTOP/TOTP handover and application of lessons learned.

This role is responsible for ensuring compliance with all applicable regulatory, JJ Quality standards and industry practices in Capital Projects.

A suitable candidate for this role will have strong working relationships with partners (project delivery, quality, operation, system owner and tech. Transfer) to ensure high quality results meeting cGMP and site quality requirements. Will also be a self-starter with strong interpersonal, organizational, and technical skills.

Key Responsibilities:

Lead the CQ and EDC team:

Lead the team of internal and external resources that will deliver CQ effort in the project.

Collaborate with Project Delivery:

Drive the adoption of Risk Based Qualification in capital projectsDrive the adoption of E2E CQ Digital validation in capital projectsEnsure alignment with JJ standards along with engineering methodologies and practices.

Provide guidance to the overall Project Execution Plan to ensure CQ is accurately defined in alignment with EPS practices:

Review affiliate qualification practices/procedures with respect to the project set up and intended CQ approachSupport local affiliate in any adjustments which may be required with the aim of crafting a robust, efficient CQ strategy to suit the projectEnsure automation / process control strategy is aligned with the overall CQ strategyDevelop / support project handover strategy to the end users. Strategy to include training, operational readiness, document handover, operation strategy, as well maintenance and housekeeping strategy)

Supports project, in effectively scheduling, coordinating, mentoring and reviewing project activities with appropriate functional groups:

Support the setup of a project CQ strategy and detailed planLead the development of proposed CQ schedule and start-up sequence (dependencies of systems), and resource loadingSupport and advice on set up of project change management programSupport Engineering Document Control process, including VTOP/TTOP handover and Drawings handover

Drive effective and efficient execution of CQ program to deliver quality project outcomes meeting performance expectations:

Set up and chair strategic and tactical CQ workshops during capital projects to ensure alignment and identify gaps, then close gaps with project team as appropriateLead project stage gate reviews for CQ to ensure strategy is being implemented accurately and support issues as necessaryReport out on CQ progress to senior managementResponsible for leading commissioning and qualification phase advancementResponsible for appointing CQ contractAccountable for safe, on time, on budget completion of all CQ Firm field execution activitiesLead all aspects of review and approval of all capital project specific engineering CQ documentationMonitor and evaluate contractor safety performance throughout the duration of the projectProvide guidance to project contractors to ensure Site CQ Program methods are being used per procedures

Lead Engineering Document Control process and VTOP/TTOP handover:

Ensure VTOP/TTOP process is aligned to JJ standardEnsure VTOP/TTOP process is managed fully digital, till handover phaseEnsure VTOP/TTOP is verified and aligned to JJ expectationsEnsure all project drawings are as-built accurately and all drawings are uploaded to Enterprise drawing management system

Johnson Johnson is seeking a highly skilled Director, Commissioning Qualification in the Commissioning Qualification field. This position will be located in North Carolina.

At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

For more than 130 years, diversity, equity inclusion (DEI) has been a part of our cultural fabric at Johnson Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson Johnson, we all belong.

Apply now to join our ambitious team and make a meaningful impact on the world through our outstanding engineering opportunities at Johnson Johnson.

In this role as Director, Commissioning Qualification, you will have the exceptional opportunity to lead the CQ activities and Engineering Document Control in large capital projects, from Strategy to Business Readiness, including aspects of project planning, resource management, execution logistics, close-out, document management, VTOP/TOTP handover and application of lessons learned.

This role is responsible for ensuring compliance with all applicable regulatory, JJ Quality standards and industry practices in Capital Projects.

A suitable candidate for this role will have strong working relationships with partners (project delivery, quality, operation, system owner and tech. Transfer) to ensure high quality results meeting cGMP and site quality requirements. Will also be a self-starter with strong interpersonal, organizational, and technical skills.

Key Responsibilities:

Lead the CQ and EDC team:

Lead the team of internal and external resources that will deliver CQ effort in the project.

Collaborate with Project Delivery:

Drive the adoption of Risk Based Qualification in capital projectsDrive the adoption of E2E CQ Digital validation in capital projectsEnsure alignment with JJ standards along with engineering methodologies and practices.

Provide guidance to the overall Project Execution Plan to ensure CQ is accurately defined in alignment with EPS practices:

Review affiliate qualification practices/procedures with respect to the project set up and intended CQ approachSupport local affiliate in any adjustments which may be required with the aim of crafting a robust, efficient CQ strategy to suit the projectEnsure automation / process control strategy is aligned with the overall CQ strategyDevelop / support project handover strategy to the end users. Strategy to include training, operational readiness, document handover, operation strategy, as well maintenance and housekeeping strategy)

Supports project, in effectively scheduling, coordinating, mentoring and reviewing project activities with appropriate functional groups:

Support the setup of a project CQ strategy and detailed planLead the development of proposed CQ schedule and start-up sequence (dependencies of systems), and resource loadingSupport and advice on set up of project change management programSupport Engineering Document Control process, including VTOP/TTOP handover and Drawings handover

Drive effective and efficient execution of CQ program to deliver quality project outcomes meeting performance expectations:

Set up and chair strategic and tactical CQ workshops during capital projects to ensure alignment and identify gaps, then close gaps with project team as appropriateLead project stage gate reviews for CQ to ensure strategy is being implemented accurately and support issues as necessaryReport out on CQ progress to senior managementResponsible for leading commissioning and qualification phase advancementResponsible for appointing CQ contractAccountable for safe, on time, on budget completion of all CQ Firm field execution activitiesLead all aspects of review and approval of all capital project specific engineering CQ documentationMonitor and evaluate contractor safety performance throughout the duration of the projectProvide guidance to project contractors to ensure Site CQ Program methods are being used per procedures

Lead Engineering Document Control process and VTOP/TTOP handover:

Ensure VTOP/TTOP process is aligned to JJ standardEnsure VTOP/TTOP process is managed fully digital, till handover phaseEnsure VTOP/TTOP is verified and aligned to JJ expectationsEnsure all project drawings are as-built accurately and all drawings are uploaded to Enterprise drawing management system

Education:

University/Bachelor’s or equivalent degree in Engineering or other related scientific field from an accredited institution required; Masters/MBA preferredExperience and Skills:

Required:

Minimum of ten to twelve (10-12) years of relevant experienceExperience in the pharmaceutical industry including capital projects, process engineering, equipment design, commissioning qualificationMulti-regional / Global experienceProven knowledge of CQ methodologies and the current industry guides and practicesStrong knowledge of GxP requirementsExperience developing cost estimates and budgetsStrong capability to collaborate with and influence technical leaders across different JJ sectors and functions, as well as external project partners (AE firms, CE firms. CQ partners, etc.)Experience in leading groups of internal and external team membersKnowledge of local regulatory requirements relevant to pharmaceutical and/or medical devices facilitiesWorking knowledge of engineering documentation control processes and systemsExcellent problem solving and fixing abilitiesProven experience in establishing external contacts and benchmarkingStrong negotiation skillsGlobal and enterprise-wide mentality coupled with strong communication skills (verbal written), and the ability to articulate ideas to influence different levels of leadership ensuring alignment of CQ methodologies across projects and sectorsPreferred:Diverse knowledge in the pharmaceutical industry, with exposure to product development, tech transfer, and quality is an additional asset but not requiredAdvanced training skillsOther:Must be proficient (written and spoken) in the English languageThis position will require up to 50% domestic and international travelPMP Certification preferredSix Sigma Black Belt Certificate preferred

Johnson Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Education:

University/Bachelor’s or equivalent degree in Engineering or other related scientific field from an accredited institution required; Masters/MBA preferredExperience and Skills:

Required:

Minimum of ten to twelve (10-12) years of relevant experienceExperience in the pharmaceutical industry including capital projects, process engineering, equipment design, commissioning qualificationMulti-regional / Global experienceProven knowledge of CQ methodologies and the current industry guides and practicesStrong knowledge of GxP requirementsExperience developing cost estimates and budgetsStrong capability to collaborate with and influence technical leaders across different JJ sectors and functions, as well as external project partners (AE firms, CE firms. CQ partners, etc.)Experience in leading groups of internal and external team membersKnowledge of local regulatory requirements relevant to pharmaceutical and/or medical devices facilitiesWorking knowledge of engineering documentation control processes and systemsExcellent problem solving and fixing abilitiesProven experience in establishing external contacts and benchmarkingStrong negotiation skillsGlobal and enterprise-wide mentality coupled with strong communication skills (verbal written), and the ability to articulate ideas to influence different levels of leadership ensuring alignment of CQ methodologies across projects and sectorsPreferred:Diverse knowledge in the pharmaceutical industry, with exposure to product development, tech transfer, and quality is an additional asset but not requiredAdvanced training skillsOther:Must be proficient (written and spoken) in the English languageThis position will require up to 50% domestic and international travelPMP Certification preferredSix Sigma Black Belt Certificate preferred

Johnson Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.