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The Senior Engineer leads and manages technical aspects of facilities and process automation, including validation, engineering projects, and capital investments. They are responsible for ensuring system reliability, regulatory compliance, and operational efficiency across pharmaceutical facilities.
Candidates must have a Bachelor's degree in Engineering and 7-10 years of experience in automation, controls, and validation within a regulated industry. Strong project management skills and extensive knowledge of GMP and FDA regulations are required.
Introduction to role
The Senior Engineer, Automation Controls – Facilities & Engineering is responsible for leading and managing the technical aspects of facilities and process automation/controls, including development and validation, engineering projects, and capital investments within a pharmaceutical organization. This role involves providing expert technical guidance, overseeing complex projects, and ensuring that all systems and processes meet regulatory requirements and support operational efficiency.
Accountabilities
Leadership and Oversight:
Lead technical teams and provide guidance on facilities and process automation/controls, including development and validation activities, engineering solutions, and capital projects.
Mentor and support junior engineers and other technical staff in development of cross functional support for automated systems.
Collaborate with cross-functional teams to align engineering and project activities with organizational goals.
Facilities Management:
As asset owner, oversee the maintenance and operation of automation/control systems and equipment within the site including critical facilities/utilities, laboratories, production areas, and administrative spaces.
Develop and implement strategies for facility automation/controls improvements and upgrades to enhance operational efficiency and compliance.
Ensure automation/controls systems adhere to health, safety, and environmental regulations.
Validation Management:
Lead the development and execution of validation strategies, protocols, and documentation for site systems, equipment, and processes with focus on assets associated with automation/controls.
Ensure that validation activities meet regulatory requirements (e.g., FDA, EMA) and internal standards.
Manage complex validation projects, including protocol design, execution, and reporting.
Automation/ Controls Oversight:
Oversee automation/controls programs to ensure the reliability of systems including electrical components, software environments, and automated field devices.
Develop and implement maintenance and inspection programs for critical equipment.
Ensure automation/controls engineering procedures and processes comply with industry standards and regulatory requirements.
Engineering Leadership:
Lead engineering projects related to the design, installation, and commissioning of systems and equipment.
Ensure engineering activities adhere to Good Manufacturing Practices (GMP) and other relevant regulations.
Develop and implement preventive and predictive maintenance programs to enhance equipment reliability.
Capital Projects Management:
Manage all aspects of capital projects, including automation/controls systems upgrades, expansions, and new installations.
Develop project plans, budgets, and schedules; monitor progress and ensure projects are completed on time and within budget.
Coordinate with internal stakeholders, external contractors, and vendors to achieve project objectives and compliance.
Documentation and Reporting:
Prepare and review comprehensive documentation for qualification/validation, engineering procedures and work instructions, and capital projects.
Generate detailed reports on project status, validation results, project activities, and asset ownership/maintenance work.
Ensure that documentation is accurate, complete, and compliant with regulatory requirements.
Compliance and Safety:
Ensure all facilities, systems, and processes comply with regulatory requirements and industry standards.
Develop and enforce safety protocols and emergency response plans.
Conduct regular audits and inspections to ensure compliance and address any issues promptly.
Continuous Improvement:
Identify and implement process improvements to enhance efficiency, reduce costs, and improve system reliability.
Stay current with industry trends, technological advancements, company guidance, and regulatory changes to ensure best practices are applied.
Essential Skills/Experience
Bachelor’s degree in Engineering, Electrical Engineering preferred, or a related engineering field; Master’s degree preferred.
7-10 years of experience in automation/controls software and equipment systems, with background in qualification/validation, facilities engineering, and capital projects. Significant experience in a pharmaceutical or regulated industry is preferred.
Extensive knowledge of GMP, FDA regulations, and other relevant compliance requirements.
Proven experience in leading complex automation/controls processes, asset ownership, engineering projects, and capital investments.
Strong project management skills with experience in budgeting, scheduling, and resource allocation.
Excellent analytical, problem-solving, and communication skills.
Ability to manage multiple priorities and work effectively under pressure.
Working Conditions:
Office and on-site facilities environment, with occasional travel to various company sites or off-site locations.
May require occasional evening or weekend work to address urgent issues or project needs.
Desirable Skills/Experience
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
AstraZeneca is a place where every day brings new challenges. We lead from the front to ensure everyone's voice is heard on site while building trust and respect with our teams. Our adaptable nature allows us to draw on diverse expertise across functions to overcome obstacles. We champion ideas from anyone on our site with a drive to see things through. Our supportive team environment ensures we succeed together by looking out for each other. With opportunities for growth beyond your role in a stable company committed to eliminating emissions by 2025, AstraZeneca is where you can make a real impact.
Ready to take on this exciting challenge? Apply now!
The annual base pay for this position ranges from $ 146,721.60 - $220,082.40. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
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