Process Engineer

Role Summary:

• An exciting opportunity has arisen for a Contract Process Engineer – Drug Product Fill / Finish based at our client’s biopharmaceutical Waterford facility.
• The purpose of the role is to provide process engineering support to Sterile Fill Finish Drug Product and the Tech Transfer process to facilitate the manufacture of commercial and clinical products.
• The successful candidate will be reporting to the Lead Process Engineer.

Core Duties and Responsibilities:

• Provide process engineering support to Sterile Fill Finish product teams & projects
• Work cross functionally to establish integrated plans to drive Tech Transfers according to key milestones
• Define and review equipment specification and associated test documentation for Tech Transfers
• Develop critical process parameters (CPP’s) and Critical Quality Attributes (CQA’s) according to tech transfer plans (i.e. cycle development, Eng Runs. Etc)
• Understand and manage critical path activities for Tech Transfers
• Perform Facility and Process Gap Assessments in the Tech Transfer Process
• Liaise with vendors on disposable technologies and process integration
• Troubleshoot equipment issues with particular emphasis on process cycles (e.g. cleaning, sterilizing)
• Develop new manufacturing processes and technologies for Tech Transfer
• Strong focus on disciplined root cause analysis
• Monitor process risk and ensure mitigations are in place as required
• Comply at all times with the Health, Safety and Environmental policy and associated procedures.
• Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
• Ensure all work carried out, complies with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines.
• Take ownership for quality compliance in all activities under the responsibility of the role

Minimum Qualifications and Experience:

• Qualified to a minimum of Degree level in engineering or related discipline
• Minimum 4 years of Process Engineering experience within a relevant Pharma, environment (preferably within a sterile manufacturing environment)
• Experience with cGMP compliance
• Capable of developing and implementing solutions to complex problems within a team dynamic using proven problem-solving techniques
• Experience with engineering processes through a logical, data driven, hands on approach
• Use of FMEA, FMECA and Risk assessment techniques
• Experience with audits (internal and external) providing technical assurance from a quality and safety perspective
• Strong report writing skills
• This role requires good judgment and strong initiative.
• Experience with prioritising and managing a diversified workload, often to tight deadlines.
• You should have strong interpersonal skills, a professional approach with excellent written and verbal communication skills.

Please note, we do not require agency assistance with this role.