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Jacobs CQV Regional Director - Candidate can be located on the East Coast or Midwest in Indianapolis, Indiana

CQV Regional Director - Candidate can be located on the East Coast or Midwest

Description

Our People & Places Solutions business – reinforces our drive to improve the lives of people everywhere and epitomizes the "why" of what we do – the tremendous positive impact and value our solutions bring to our communities and society as a whole. From facilities delivering life-saving therapies and ensuring clean water to enabling the connection of people through all modes of transportation and providing access to technology – we're integrating a multitude of these solution elements to build the smart environments of tomorrow.

Start your Jacobs career with a company that inspires and empowers you to deliver your best work so you can evolve, grow and succeed – today and into tomorrow.

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  • Candidate can be located on the East Coast or Midwest***

Job Description

The Commissioning, Qualification and Validation (CQV) Director will provide CQV services to clients in the Life Sciences Industry. The position provides an excellent opportunity to work for a Global Engineering Firm and support clients that manufacture life changing products. This hands-on Director role shall be responsible for managing the development and execution of CQV documentation on a variety of equipment, facilities, utilities, components, products, and systems for a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers.

Primary Responsibilities:

  • Directs the activities (i.e. commissioning, qualification, validation, process transfer, etc.) of cross functional teams in order to meet company and site objectives.

  • Establishes credibility throughout the organization as an effective developer of solutions to business challenges.

  • Provides leadership and management to ensure that the mission and core values of the company are put into practice.

  • Spearheads the development, communication and implementation of effective growth strategies and processes for CQV.

  • Collaborates with the executive management team to develop and implement plans for the CQV operational infrastructure of systems, processes and personnel designed to accommodate the growth objectives of the company.

  • Motivates and leads a high-performance CQV management team; attracts, recruits and retains required members of the team not currently in place including SMEs, Project Managers & CQV Specialists.

  • Acts as a partner for the Business Development team to meet sales, growth and market share objectives.

  • Designs and implements appropriate CQV marketing strategies and effectively utilizes social media to promote CQV growth.

  • Fosters a success-oriented, accountable environment within the company.

  • Serves as a trusted advisor & leader, represents the firm with clients, and business partners.

  • Works collaboratively with management and staff to identify new clients and growth opportunities.

  • Develops project cost estimates and proposals for validation for large capital projects.

  • Visits client sites and presents Jacobs CQV capabilities to potential clients.

  • Develops, monitors and reports on operating costs within functional areas. Alerts Sr. Management of cost and labor over runs. Makes recommendations and implements solutions to problems related to same.

  • Directly supervises the staff of the Validation department to achieve ongoing compliance to evolving regulatory expectations.

  • Manages, develops and supports CQV personnel and provides mentoring and guidance pertaining to CQV work processes and administrative requirements.

  • Interfaces with clients to ensure that their needs are being met.

  • Maintains knowledge of regulatory expectations, cGMPs, and industry benchmarking to ensure thorough understanding of compliance, risk management and efficient CQV support.

  • Presents at conferences and networks throughout the industry to promote Jacobs expertise in this field and the Life Sciences sector as a whole.

  • Manages accounting aspects of projects including bill rates, estimates, budgets and contractual agreements.

Qualifications

  • BS/MS in Engineering, Technical or Life Science Discipline.

  • Minimum of 10 years of experience leading and managing line of business or office in the Life Sciences industry.

  • Minimum of 15 years of Commissioning, Qualification, Validation and Compliance experience in the biopharmaceutical industry; Sound technical knowledge of CQV.

  • Extensive project management experience of small to large capital projects in life sciences.

  • Demonstrated effective leadership, financial management and collaboration skills.

  • Interpersonal and leadership skills necessary to communicate clearly and effectively and coordinate and manage qualification/validation activities with all levels of personnel from various disciplines across the organization.

  • Experience collaborating and working in large organizational or functional business units.

  • Results focused and self-motivated.

  • Excellent communication and presentation skills.

  • Flexible and willing to travel, domestic or international, as necessary.

  • Competencies: Strategic Thinking, Business Acumen, Leadership, Technical CQV knowledge, Results Driven, Financial Management, Problem Solving/Analysis, Collaboration Skills, Presentation Skills, Interpersonal Skills

  • Engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients

  • Proposal development experience

  • Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations

  • Knowledge of industry guidance on CQV and CSV:

  • ISPE Baseline Guide 5 Commissioning and Qualification, edition 2

  • ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems

  • ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

  • ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011

  • ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011

At Jacobs, we help prepare people for new opportunities and challenges. With positions at every level, openings in multiple disciplines, expertise in a range of markets and offices around the globe, we create an environment where you can learn, grow, and thrive. From our competitive benefits program to our Health and Safety initiative of Beyond Zero workplace injuries, we believe that you'll find a flourishing career here at Jacobs.

#AF #LifeSciences

Jacobs is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, or medical conditions related to pregnancy, childbirth, or breastfeeding), age, medical condition, marital or domestic partner status, sexual orientation, gender, gender identity, gender expression and transgender status, mental disability or physical disability, genetic information, military or veteran status, citizenship, low-income status or any other status or characteristic protected by applicable law. Learn more about your rights under Federal EEO laws and supplemental language.

Job Engineering

Primary Location United States-Indiana-Indianapolis-US IN Indianapolis - Jeg

Job Type Experienced

Req ID: LS-00006X

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