- An exciting opportunity has arisen for a 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 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 8 years of Process Engineering experience within a relevant Pharma. environment (preferably within a sterile manufacturing environment)
- cGMP compliance
- Capable of developing and implementing solutions to complex problems within a team dynamic using proven problem-solving techniques
- Ability to understand engineering processes through a logical, data driven, hands on approach
- Use of FMEA, FMECA and Risk assessment techniques
- Can interact 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.
- You need to have the ability to effectively prioritise and manage a diversified workload, often to tight deadlines.
- You should have strong interpersonal skills, a professional approach with excellent written and verbal communication skills.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.