Capital Project Execution Project Director – C&Q Engineering and End-Game Leader - Operations Job in Maryland (MD), Research and Development Career, Jobs in AstraZeneca Pharmaceuticals
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Capital Project Execution Project Director – C&Q Engineering and End-Game Leader - Operations job in Gaithersburg

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AstraZeneca Pharmaceuticals jobs
Maryland (MD), Gaithersburg
Job Code:  R-036896
Employer:  AstraZeneca Pharmaceuticals
Category:  Research and Development

Location
Country:  United States
State:  Maryland (MD)
City:  Gaithersburg
10/09/2018

Description
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. We're proud to have a unique workplace culture that inspires innovation and collaboration, where employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

Global Engineering delivers capital assets and technology solutions which enable AstraZeneca to meet supply chain requirements and realise business benefits across the small molecule and biologics product portfolio. We have expertise in safety, project management, engineering technical services, project services, built environment, construction management, real estate and process governance. We have a very exciting portfolio of capital projects around the world, with significant level of investment planned over the next three years, predominately in North America, Europe and AsiaPac.

We are currently recruiting for a Project Director C&Q + End Game Lead who will work within the Global Engineering (GE) Project Execution organisation. You will be home-based at the GE hub in Gaithersburg, MD with the beginning of the appointment based in Coppell, TX to support delivery of our integrated Lokelma investment program.

In this role you will be responsible and accountable for ensuring that the planning and implementation of Commissioning and Qualification strategy for sanctioned capital project investments is performed to the expectations set-out in management guidance. In addition, you shall also establish and maintain successful partnerships in the business in order to strategize and plan the efficient, timely & successful transfer of completed assets to the business unit and into operation. You will also support ongoing development and governance initiatives related to continuous improvement of our Capital Project Delivery Process (CPDP).

Whilst you will be predominately focused on the Lokelma Program in Coppell during 2018/19, this role is global and the you will need to have global mobility to potentially participate in business evaluation studies, facilitate workshops with site based clients, and build stakeholder relationships across the AstraZeneca enterprise.

As a PD and a senior member of the team, you will take an active role or be the leader of Project Assessment or Recovery initiatives. This includes simple project "health-checks", detailed Peer Reviews or even joining a particular project team for a dedicated period to achieve particular objectives.

The Project Execution team within the Global Engineering organization provides a range of services to the Operations, R&D and Commercial functions of AstraZeneca and MedImmune global businesses, including:

•Project, Programme and Portfolio Management;
•Business case assessment and opportunity evaluation for prospective capital investments across both the Engineering and Real Estate portfolios;
•Capital Project Planning and Proposal preparation;
•Detailed project execution planning and delivery right through the entire project lifecycle to a completed asset being brought into operational use.

Global Engineering Project Execution staff are located in US, UK, Sweden, France and China.
Key Accountabilities

In this role your accountabilities will include, but will not be limited to:

•Ensuring that the implementation of practical and effective C&Q execution strategy with project team from the early CPDP stages till execution completion as defined in the CPDP process.
•Lead project team establishment of an efficient asset turnover strategy for handover to the end-user, ensuring use of the most effective tools and techniques in order to achieve the most optimal transition-to-business from the project.
•Ensure that lessons-learnt and good practices of C&Q and asset turnover are shared effectively among execution team and asset owners to enable future repeatable processes and results.
•Support actions required for asset transition to business/owners are implemented to ensure benefit realization are initiated.
•Reviewing the formal documentation defining project C&Q and End Game activities on each project.
•Consulting Subject Matter Contacts and conduct Peer Reviews for ongoing Stage 4 activities.
•Ensuring industry design standards, Engineering Standards, and Engineering Best Practices are incorporated into Stage 4 deliverables across the project portfolio.
•Raising complex elements of Stage 4 & 5, including high risk issues, to Project & Portfolio Leaders/Engineering Council to obtain guidance and approval to implement.
•Actively coordinating with global and other regional teams as needed to successfully deliver projects.
•Develop & maintain effective relationships with all of the Global Engineering groups and display the ability to influence without direct authority.

In this role your responsibilities will include, but will not be limited to:

•Engage and work with each Project Manager, early in the stage of the project lifecycle (CPDP Stages 2 & 3), to set guidance and ensure that the process to develop a "fit-for-purpose" Commissioning & Qualification execution strategy and detailed plans including an agreed project turnover plan is in place.
•Support project teams in assessing project level staffing needs to ensure that appropriate C&Q staffing, expertise and leadership (both with internal and external resources) exists to successfully and safely execute projects.
•Facilitate GMP design reviews, design qualification and collaborate on the development of Project Validation Master Plans and execution of Quality Risk Assessments with project C&Q team and Engineering Technical Services (ETS) C&Q SME.
•Provide direct project support for strategic and at-risk projects to ensure successful execution of the C&Q strategy including project turnover. In addition, support project C&Q team in major critical deviation investigation and resolutions during C&Q execution.
•Participate in project assessments for active projects to identify opportunities for improvement including performing "health check". Facilitate C&Q peer reviews across projects to mitigate against unintended omissions/gaps in strategy and execution plans.
•Collaborate with ETS C&Q SME team to promote the use scientific, product and process understanding as a basis for developing risk based approaches to commissioning (No-impact systems) and qualification of (Direct Impact systems) for project C&Q teams. Ensure alignment to GERE Validation guidelines, procedures and practices by project C&Q teams.
•Participate in project lesson learnt session to gather all learning in designated knowledge base system and share with the broader group.
•Provide mentorship for project C&Q team in delivering accurate management reporting for C&Q execution and project turnover.
•Work with Project Managers and asset owners to establish "transition to business" plan which may include organizational change management to ensure that asset benefit realization is on track after project turnover.
Required Skills & Knowledge
•Bachelor's degree in engineering or related field & extensive industrial experience.
•15+ years Bio-pharmaceutical experience & knowledge, preferably with capital project experience
•Proven Leadership in C&Q project delivery
Functional

•Capital Project Delivery Subject Matter Expertise, particularly in the C&Q discipline
•Strong experience in successful transition from Project-to-Business
•Familiarity with IS/IT systems integration with process equipment & automation
•Computer system validation
•Transition to business and change programs
•Desirable experience:
•Project Benchmarking
•Risk Management
•Cost & Schedule Controls
•Track record of successfully working with different cultures plus a relevant additional language
•Knowledge of and working experience with the Lokelma franchise at the Coppell site
Core

•Project Management (Level 4)
•Business Relationship Management (Level 4)
•Conceptual Thinking (Level 3)
•Business Awareness/Acumen (Level 4)
Leadership

•Communication - strong, open & transparent
•Relationship establishment & maintenance - with a broad range of stakeholders
•Strategic Leadership - oversee and/or coordinate with multiple internal stakeholders and external leveraged partners
•Influence - has the ability to influence team actions and behaviours
•Proven team player, willing to consider & accept other views & concepts
•Drives accountability
•Acts Decisively
•Works Collaboratively
•People Development

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. We're proud to have a unique workplace culture that inspires innovation and collaboration, where employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

Global Engineering delivers capital assets and technology solutions which enable AstraZeneca to meet supply chain requirements and realise business benefits across the small molecule and biologics product portfolio. We have expertise in safety, project management, engineering technical services, project services, built environment, construction management, real estate and process governance. We have a very exciting portfolio of capital projects around the world, with significant level of investment planned over the next three years, predominately in North America, Europe and AsiaPac.

We are currently recruiting for a Project Director C&Q + End Game Lead who will work within the Global Engineering (GE) Project Execution organisation. You will be home-based at the GE hub in Gaithersburg, MD with the beginning of the appointment based in Coppell, TX to support delivery of our integrated Lokelma investment program.

In this role you will be responsible and accountable for ensuring that the planning and implementation of Commissioning and Qualification strategy for sanctioned capital project investments is performed to the expectations set-out in management guidance. In addition, you shall also establish and maintain successful partnerships in the business in order to strategize and plan the efficient, timely & successful transfer of completed assets to the business unit and into operation. You will also support ongoing development and governance initiatives related to continuous improvement of our Capital Project Delivery Process (CPDP).

Whilst you will be predominately focused on the Lokelma Program in Coppell during 2018/19, this role is global and the you will need to have global mobility to potentially participate in business evaluation studies, facilitate workshops with site based clients, and build stakeholder relationships across the AstraZeneca enterprise.

As a PD and a senior member of the team, you will take an active role or be the leader of Project Assessment or Recovery initiatives. This includes simple project "health-checks", detailed Peer Reviews or even joining a particular project team for a dedicated period to achieve particular objectives.

The Project Execution team within the Global Engineering organization provides a range of services to the Operations, R&D and Commercial functions of AstraZeneca and MedImmune global businesses, including:

•Project, Programme and Portfolio Management;
•Business case assessment and opportunity evaluation for prospective capital investments across both the Engineering and Real Estate portfolios;
•Capital Project Planning and Proposal preparation;
•Detailed project execution planning and delivery right through the entire project lifecycle to a completed asset being brought into operational use.

Global Engineering Project Execution staff are located in US, UK, Sweden, France and China.
Key Accountabilities

In this role your accountabilities will include, but will not be limited to:

•Ensuring that the implementation of practical and effective C&Q execution strategy with project team from the early CPDP stages till execution completion as defined in the CPDP process.
•Lead project team establishment of an efficient asset turnover strategy for handover to the end-user, ensuring use of the most effective tools and techniques in order to achieve the most optimal transition-to-business from the project.
•Ensure that lessons-learnt and good practices of C&Q and asset turnover are shared effectively among execution team and asset owners to enable future repeatable processes and results.
•Support actions required for asset transition to business/owners are implemented to ensure benefit realization are initiated.
•Reviewing the formal documentation defining project C&Q and End Game activities on each project.
•Consulting Subject Matter Contacts and conduct Peer Reviews for ongoing Stage 4 activities.
•Ensuring industry design standards, Engineering Standards, and Engineering Best Practices are incorporated into Stage 4 deliverables across the project portfolio.
•Raising complex elements of Stage 4 & 5, including high risk issues, to Project & Portfolio Leaders/Engineering Council to obtain guidance and approval to implement.
•Actively coordinating with global and other regional teams as needed to successfully deliver projects.
•Develop & maintain effective relationships with all of the Global Engineering groups and display the ability to influence without direct authority.

In this role your responsibilities will include, but will not be limited to:

•Engage and work with each Project Manager, early in the stage of the project lifecycle (CPDP Stages 2 & 3), to set guidance and ensure that the process to develop a "fit-for-purpose" Commissioning & Qualification execution strategy and detailed plans including an agreed project turnover plan is in place.
•Support project teams in assessing project level staffing needs to ensure that appropriate C&Q staffing, expertise and leadership (both with internal and external resources) exists to successfully and safely execute projects.
•Facilitate GMP design reviews, design qualification and collaborate on the development of Project Validation Master Plans and execution of Quality Risk Assessments with project C&Q team and Engineering Technical Services (ETS) C&Q SME.
•Provide direct project support for strategic and at-risk projects to ensure successful execution of the C&Q strategy including project turnover. In addition, support project C&Q team in major critical deviation investigation and resolutions during C&Q execution.
•Participate in project assessments for active projects to identify opportunities for improvement including performing "health check". Facilitate C&Q peer reviews across projects to mitigate against unintended omissions/gaps in strategy and execution plans.
•Collaborate with ETS C&Q SME team to promote the use scientific, product and process understanding as a basis for developing risk based approaches to commissioning (No-impact systems) and qualification of (Direct Impact systems) for project C&Q teams. Ensure alignment to GERE Validation guidelines, procedures and practices by project C&Q teams.
•Participate in project lesson learnt session to gather all learning in designated knowledge base system and share with the broader group.
•Provide mentorship for project C&Q team in delivering accurate management reporting for C&Q execution and project turnover.
•Work with Project Managers and asset owners to establish "transition to business" plan which may include organizational change management to ensure that asset benefit realization is on track after project turnover.
Required Skills & Knowledge
•Bachelor's degree in engineering or related field & extensive industrial experience.
•15+ years Bio-pharmaceutical experience & knowledge, preferably with capital project experience
•Proven Leadership in C&Q project delivery
Functional

•Capital Project Delivery Subject Matter Expertise, particularly in the C&Q discipline
•Strong experience in successful transition from Project-to-Business
•Familiarity with IS/IT systems integration with process equipment & automation
•Computer system validation
•Transition to business and change programs
•Desirable experience:
•Project Benchmarking
•Risk Management
•Cost & Schedule Controls
•Track record of successfully working with different cultures plus a relevant additional language
•Knowledge of and working experience with the Lokelma franchise at the Coppell site
Core

•Project Management (Level 4)
•Business Relationship Management (Level 4)
•Conceptual Thinking (Level 3)
•Business Awareness/Acumen (Level 4)
Leadership

•Communication - strong, open & transparent
•Relationship establishment & maintenance - with a broad range of stakeholders
•Strategic Leadership - oversee and/or coordinate with multiple internal stakeholders and external leveraged partners
•Influence - has the ability to influence team actions and behaviours
•Proven team player, willing to consider & accept other views & concepts
•Drives accountability
•Acts Decisively
•Works Collaboratively
•People Development

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

ref: (R-036896)
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