Process Engineer

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About Astellas

At Astellas we are making treatments that matter to people.

Description

Process Engineer

About Astellas

At Astellas we are making treatments that matter to people.

We are tackling the toughest health challenges putting the patient at the heart of every move we make.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.

We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives.

From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.

The Opportunity

As the Process Engineer, you will provide technical support to Operations Department, including effective investigation/ root cause analysis and implementation of corrective actions, to ensure efficient production operation and to support manufacturing schedule adherence.

You will also ensure compliance of the above function with all internal and external regulatory, legislative, and statutory requirements.

Key Responsibilities

• Technical Support and Compliance: Provide technical support to manufacturing operations to ensure efficient production operation, and to support manufacturing schedule adherence, including a) proactive problem solving and resolution of process issues, and b) effective investigation/ root cause analysis for plant and control issues to meet procedural timelines, and implementation of corrective actions.
• System Management and Data Integrity: Administration of DCS and other control systems in operational areas, ensuring a) system compliance with all site standards and procedures and b) maintaining a high level of system operational performance and maintaining data integrity.
• Operational Input and Direction: To provide strategic value add operational input and direction in support of the plant's technical operational activities and requirements, including support to projects/ initiatives in the manufacturing areas.
• Operational Excellence and Continuous Improvement: Actively support the Operational Excellence Programme, coordinate continuous improvement activities using Lean Six Sigma, and lead forums to review progress. Manage and/or support activities to maximise value (e.g. increase revenue, reduce costs) such as (but not limited to) process optimisation, waste reduction/recycling, energy saving etc.
• Compliance: Ensure compliance with relevant regulations and standards associated with cGMP, ISO 14001, ISO 45001, Health & Safety Legislation and Environmental Legislation, and also all site standards, policies, and procedures. Support other sections to ensure such compliance also. Includes maintenance of production control systems.
• Projects/ Initiatives: Manage and/or support projects and other initiatives, which may be of a technical or non-technical nature. Working closely with cross functional teams as required.
  
  

Essential Knowledge & Experience

• Experience in a cGMP API environment is preferred along with technical proficiency, including a) broad understanding of filtration and purification technologies and processes, b) process instrumentation , c) equipment qualification, d) process validation, and e) experience with process control systems (DCS, PLC) would be an advantage.
• Possesses excellent organisational, interpersonal, verbal communication and written communication skills.
• Ability to work effectively, and prioritise multiple commitments, using own initiative or as a member of a team as required. Ability to shift priorities according to changes in department/facility needs and be open to different ideas/approaches.
• Proven analytical and problem-solving skills, including Lean Six Sigma proficiency.
  
  

Education

• B.S. in Engineering, Chemical / Biochemical discipline or equivalent.
  
  

Additional Information

• This is a permanent full-time position.
• Position is based in Dublin – Ireland.
• This position requires you to be 100% on site / in the office.
  
  

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Seniority level

• Seniority levelEntry level

Employment type

• Employment typeFull-time

Job function

• Job functionManagement and Manufacturing
• IndustriesPharmaceutical Manufacturing

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