Process Safety Manager - APICOM

Process Safety Manager

Location: Ireland, Dublin

Full time/Permanent

Competitive salary and benefits

Job Description

AstraZeneca is building a new API facility to accelerate commercial product launches, enhance productivity and deliver innovative, sustainable API manufacturing. Future-proofed digital solutions will be integrated with operational technology to enable highly efficient batch and continuous processing.

The Process Safety Manager is the primary point of contact for all process safety elements of the new Active Pharmaceutical Ingredient (API) facility being constructed at the Alexion Campus, College Park, Dublin.

Initially, the Process Safety Manager will be part of a team providing technical support to ensure the design of this facility is safe and efficient, and that long-term operability is factored in, including input to URS, P&ID, equipment selection, various PHA methodologies, COMAH/SEVESO application and generation/maintenance of the site Major Accident Prevention Policy.

They will be accountable for developing a new process safety management system, change management, safety regulation compliance, safe systems of work, developing process safety key performance indicators giving assurance of control of major hazard risks, emergency response program and training to cover the API manufacturing plant and its external infrastructure (e.g. for waste handling and emissions abatement), the warehouse and the QC and development labs. They will also ensure those systems are effectively integrated with the EHS management system of the existing Biologics operations facility on the College Park site.  They will be the key point of contact with the HSA regarding site COMAH inspections.

They will support the client team and act as a liaison between the client team, project team, and partners to ensure detailed operation and integration of process safety systems in compliance with industry and regulatory standards.

In the long term, the Process Safety Manager will be responsible for providing technical leadership across all the process safety systems within and associated with the API facility. They will be accountable for the compliance, performance, and sustainable operation of those systems.

This position requires a strong technical background in process safety systems and the ability to collaborate effectively with both internal and external partners.

Typical Accountabilities

Safety, Health and Environment

Promoting an environment of no hurt, harm or alarm

• Work in a manner that promotes the safety and well-being of self, others and the environment

• Chip into improving SHE performance, proactively use SHE Reporter to identify SHE hazards and take appropriate actions

GMP / Compliance and Ethical Conduct

Ensuring compliance of self and others to internal and external regulations

• Align with all systems, processes and procedures in line with statutory/ legislative / quality requirements

• Conduct activities and interactions consistent with What we value and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.  Finish the required training on the AZ Code of Conduct and supporting Policies and Standards on time.   Report potential issues of non-compliance.

Delivery / Supply

• Ensuring customer service is always considered.

Cost

• Promoting a cost-conscious environment to enable effective cost management.

Lean & Agile Culture / Standardised ways of working

• Ensure all work is carried out in accordance to approved and established processes and procedures.

You will need to have:

• Ideally, hold a PhD/BSc in either Chemistry or a relevant Engineering/Science field and have a good understanding of the drug development process and API/Chemical Manufacturing operations from process development through to the launch of products.

• A significant number of years experience working within a Process Safety environment in order to gain the breadth of knowledge required to be an expert in the field.

• A comprehensive understanding of the subject areas involved in Process Safety and the role it plays both within Process Development and API/Chemical manufacturing.

• Ability to think across functional boundaries, challenge the status quo and seek opportunities for business improvement.

• Ability to analyse and interpret complex situations and provide clear strategic directions for others.

• Excellent communication and influencing skills across interfaces of subject area, culture, and expertise.

• Excellent teamwork and networking skills and encourages team effectiveness.

• Experience in facilitation.

• Innovative with an interest in standard process and new developments within the pharmaceutical industry, will be able to engage peers and challenge old ways of working.

• Excellent awareness of the principles, applications and management of SHE and cGMP.

What we would prefer you to have:

• Strong Maths & Chemistry/Science background.

• Proficient in MS Office tools.

• Understanding of Chemical and Fire/explosion hazards and the assessment of them.

• Working knowledge of Consequence Modelling, e.g., ALOHA/PHAST

• Working understanding of ATEX requirements, Hazardous Area Classification, Explosion protection methodologies, Occupied Building Risk Assessment and Human Factor Risk Assessment methodologies. 

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 fuel 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!

Where can I find out more?

Our Social Media,

Follow AstraZeneca on LinkedIn

Follow AstraZeneca on Facebook

Follow AstraZeneca on Instagram

Date Posted

Closing Date