Senior Process Development Engineer

Senior Process Development Engineer

Role Description

POSITION SUMMARY

The Senior Process Development Engineer is responsible for leading process validation, process development, and lifecycle management activities through laboratory-based studies and technical assessments. The role provides scientific and engineering support for optimization of manufacturing processes, ensuring robust scale-up, validation readiness, process improvements, and continued process performance.

The successful candidate will design and execute laboratory investigations, evaluate process changes, generate and maintain process control documentation, and assess the impact of process modifications on validation and Process Performance Qualification (PPQ) strategies. Working cross-functionally with Operations, Quality, Regulatory Affairs and Engineering, the successful candidate will play a key role in ensuring products are manufactured safely, compliantly, and efficiently throughout their lifecycle.

POSITION RESPONSIBILITIES

Process Development & Technical Support

• Design, execute, and document laboratory studies to improve process understanding and support manufacturing operations.
• Analyse experimental data and provide scientifically justified recommendations.
• Support technical investigations relating to process performance, deviations, and non-conformances.
• Apply engineering and scientific principles to identify opportunities for process optimization and continuous improvement.

Scale-Up and Technology Transfer

• Assess scalability of laboratory-generated data and determine potential manufacturing impacts.
• Support process scale-up activities from laboratory to commercial manufacturing.
• Collaborate with manufacturing teams to ensure successful implementation of process changes.
• Provide technical assessments and recommendations associated with process transfers and technology deployment.

Process Control Strategy

• Develop, review, and maintain process control documents.
• Define critical process parameters and their associated control strategies.
• Support ongoing monitoring and trending of process performance metrics.
• Ensure process documentation remains aligned with current manufacturing practices and regulatory expectations.

Validation and PPQ Support

• Evaluate proposed process changes for impact on validation status and PPQ requirements.
• Support development and execution of validation protocols and reports.
• Provide technical justification for validation approaches and acceptance criteria.
• Participate in change control activities, ensuring validation implications are appropriately assessed and documented.

Quality and Compliance

• Ensure all activities are executed in accordance with GMP requirements and company procedures.
• Support/lead investigations, CAPAs, change controls, and risk assessments.
• Maintain accurate laboratory records and technical documentation.
• Contribute to regulatory inspections and internal audits as required.
• Conduct laboratory experiments in a safe manner following site procedures.
• Participate in department & site internal safety GEMBAs, inspections and sustainability initiatives.

Continuous Improvement

• Support operational excellence initiatives through structured problem-solving methodologies.
• Participate in Lean, Six Sigma, and continuous improvement projects.
• Identify opportunities to enhance process robustness, product quality, and manufacturing efficiency
• The ideal candidate will possess a strong interest in emerging technologies and digital transformation within pharmaceutical manufacturing i.e. PAT & AI-driven approaches to process understanding.

SYSTEM OWNER / SUBSYSTEM OWNER RESPONSIBILITIES

System Owner (SO) System Owners have overall accountability for the site Quality Systems for which they are responsible and in particular for:

• Providing strategic & proactive direction with respect to the System (across the site) in terms of content and execution.

• Providing support, guidance & coaching to Sub System Owners (SSO).

• Ensuring that SSO regularly review sub-systems for their effectiveness, escalating issues where required to site Quality Council (QRC) for action & remediation.

• Owning relevant System issues in the site Compliance Plan.

• Defining resources as needed & communicating resource needs to Site Lead.

• Applying people change control across Sub-Systems within their responsibility.

• Ensuring that SSO have proactive continuous improvement plans for their Sub-Systems.

Sub System Owner (SSO) Sub-System Owners have overall accountability for the site Quality Sub-Systems for which they are responsible and in particular for:

• Providing strategic & proactive direction with respect to their Sub-System (across the site) in terms of content and execution.
• Regularly reviewing their Sub-System & presenting Sub-System review to Quality Council (QRC) as required. Escalating issues where required to the System Owner (SO) and site QRC for action and remediation.
• Owning relevant Sub-System issues in the site Compliance Plan.
• Defining resources as needed & communicating resource needs to SO.
• Developing & implementing proactive continuous improvement plans for their sub-system.
• In partnership with the SO, ensuring that there are clearly defined expert(s) for each sub-system, acting as a point of contact during inspections.
• Overseeing all documents associated with their sub-system and providing input to the document owners during updates.
• Providing comments on new/revised draft policies and guidelines and completing impact assessments where required.

ORGANISATIONAL RELATIONSHIPS

• Directly reports to the GMT Leader or designee.
• Strong working relationship with all employees across all departments.
• All employees are expected to model Zoetis Core Beliefs. Each team member can influence and bring knowledge to their work and teams during their day-to-day interactions.
• This position will require fluent use of teleconferencing tools, as well as SharePoint technologies, to share and manage information with internal teams, Commercial Manufacturing Organizations (CMOs) and Veterinary Medicine Research and Development (VMRD)

EDUCATION AND EXPERIENCE

Experience

• At least 7 years’ experience in a technical role in the API industry.

Education

• Degree in Chemical/Process Engineering

• TECHNICAL SKILLS AND COMPETENCIES REQUIRED

• Experience with scale-up techniques for processes from laboratory to plant scale.

• Familiarity with commercial scale equipment and processes.

• Mastery of chemical engineering principles, practices and theories with pharmaceutical experience.

• Understanding of regulatory and quality requirements.

• Demonstrated ability to work effectively in cross functional and culturally diverse work environment. The ability to confidently assert a technical position in the face of opposition.

• Foster a culture of inclusion, agility, continuous improvement and innovation.

• Proven record of consistent performance.

• Commitment to delivering results.

• Demonstrated excellence in planning and organizational skills.

• Demonstrated skills in communication (oral and written) – particularly technical writing

• Willingness to travel occasionally, including international travel, as needed

• PHYSICAL POSITION REQUIREMENTS

• This is a Rathdrum Site based position however travel occasionally, including international travel may be required.

• Declaration

• I acknowledge that I have read and understand the above job description in its entirety and can meet all requirements of this role. I declare that I am not aware of any impediments including any convictions that would prohibit or conflict with the execution of this role. I understand that any false information or deliberate omission in the information I have provided to the company prior to this point may result in my dismissal.

• Full time

• Legal statement as below

• This job advert indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required. Additional position specific requirements/responsibilities are contained in approved training curricula.

• Visa status re must be eligible to work and live in Ireland as below

• Colleague must be legally eligible to live and work in Ireland.

• Summary of our Benefits

• In addition, to being part the world leading animal health company focused on the needs of those who raise and care for animals we offer a range of benefits such as competitive salary, bonus, 25.5 days holiday per annum plus public holidays, a defined contributory pension plan, private medical insurance for you and your family and empowered flexibl