OT/IT Governance SME

Location: Macclesfield UK, Gothenburg Sweden, Gaithersburg US.

Competitive Salary and Benefits package

Hybrid working 3 days a week in the office

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

As a high performing team, we are united and motivated by our shared purpose – to push the boundaries of science to deliver life-changing medicines. We come to work each day to make a difference – to patients, society, and our company.

Here you will experience a fast paced and agile environment as we continue to support the business on a journey of evolution and growth, driven by new, exciting technology and digital innovations. It’s challenging and sometimes demanding, and that’s why we love it.

Job Description

The OT/IT Governance SME will be responsible for establishing and guiding site-based teams on the technology solutions utilized within our manufacturing facilities.

Responsibilities

• Act as a technical resource to GERE, IT and the sites group to support and deliver technical advice and Automation solutions to resolve manufacturing issues and improve operational performance

• Understand Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Windows based PC’s and VM’s and industrial network architectures and how to effectively apply these technologies to a pharmaceutical manufacturing environment

• Actively collaborate as a team member in a high-performance cross functional work team environment

• Act as a leader to support and drive OT and IT standards adoption and implementation across the engineering and manufacturing enterprise

• Support standardization of the design and delivery as it pertains to Manufacturing Intelligence and Execution Systems.

• Recognize potential gaps in infrastructure and develop solutions that can adapt to various engineering designs, applications and process criteria

• Support continuous improvement efforts through delivery of information from manufacturing IT systems.

• Train others on systems, software, equipment, machines, procedures, and/or processes.

• Write, review and approve documentation such as standards as well as qualification documentation

• Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures)

• Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes

• Coordinate the activities of third party personnel

• Using lean tools, find ways to eliminate waste and streamline processes

• Consult on the design, implementation, and support of site-wide process automation, supervisory control, and data acquisition (SCADA) solutions.

• Assist with executing validation protocols for processes, equipment, packaging, and/or cleaning.

• Conduct presentations (other than training) for different audiences.

• Evaluate new software and/or tools.

• Support capital projects to ensure on-time and in-budget completion.

• Participation in industry groups promoting standardization (ex: ISPE, etc.)

• Understand current and emerging industry OT and IT standards that can improve our ability to deliver assets in the most efficient manor that deliver the most bene

Typical Accountabilities

For Employees:

Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.

For Managers and Project Team Leaders:

Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.

Accountabilities at AstraZeneca include:

Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.

Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality System and continually improve its effectiveness

Essentials

• Bachelor’s degree in Engineering, Computer Science or related discipline or equivalent

• Minimum 10 years of experience supporting automation and manufacturing intelligence systems

• Experience with manufacturing IT (i.e., Manufacturing Execution Systems, Historian technologies, reporting systems)

• Familiarity with Windows operating systems, domains, Ethernet networks

• Analytical and data driven

• Concise, accurate and focused on details

• Excellent communication and documentation skills

• Ability to build effective relationships

• Confidence when engaging with stakeholders

• Experience with problem solving

• Ability to work independently and as part of a team.

• Able to influence through collaboration.

• Understanding of S95 architecture, and in particular how systems integrate from level 3 down

Desirables

• Experience with managing projects and leading engineers

• Experience with PLC and DCS systems such as Rockwell/Allen Bradley, Siemens, Emerson/DeltaV

• Experience with Allen Bradley, Wonderware, or Siemens SCADA platforms

• Experience with OSIsoft PI

• Knowledge of change control, validation and qualification principles

• Experience with Lean & Manufacturing Excellence tools

• Understanding of S88 recipe structure principles

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and spark your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours

Where can I find out more?

Our Social Media,

• Follow AstraZeneca on LinkedIn - LinkedIn

• Follow AstraZeneca on Facebook - Facebook

• Follow AstraZeneca on Instagram - Instagram

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.