Process Scientist

2 weeks ago

Sligo, Sligo, Ireland Sigmar Recruitment Full time
About Your New Employer Join a leading biotechnology and pharmaceutical companywith a strong commitment to quality and innovation.
Work at our state-of-the-art facility in Sligo, Ireland, where cutting-edge technology and processes are at the forefront of our operations.
Be part of a dynamic and collaborative teamthat values excellence, continuous improvement, and professional growth.
About Your New Job As the Process Scientist, you will be an integral part of our Quality team, focusing on Technical Transfer (TT) activities to ensure successful transfer of processes and technology.
Your responsibilities will include: Planning and coordinating TT activitiesto support new product introductions and product support.
Developing instructions for production operationssuch as tableting and packaging.
Reviewing and reporting on TT activity dataand working with the scheduling team to ensure timely execution.
Supporting the Manufacturing teamthroughout the manufacturing process and developing necessary protocols.
Using a risk-based approachfor planning, readiness, and execution of TT activities.
Developing functional partnershipswith site business units to address TT-related issues.
Providing on-the-floor process supportand introducing statistically based tracking metrics.
Monitoring process CPPsand updating process databases.
Investigating and closing out non-conformances, deviations, and change control requests.
Performing sample analysisand coordinating external test laboratories when required.
Presenting issues and developing business casesfor courses of action as appropriate.
Engaging with and supporting Quality and Regulatory Audits.
What Skills You Need A minimum of a Master's degreein a technical discipline (e.g., biochemistry, chemistry, biotechnology, biopharmaceuticals).
A Ph D is desirable.
At least 5 years of experiencein the biotechnology and/or pharmaceutical industry, with operational experience in new product introductions and product support.
Knowledge of pharmaceutical manufacturing processes and equipment(oral solid dose, parenterals, and/or biologicals).
Experience in authoring, reviewing, and executing process validation studies and reports.
Experience with vaccinesis preferable, particularly in product development and stewardship.
Proficiency in written and spoken English.
Excellent understanding of GMP, ICH, and compendia regulations and guidance.
Strong problem-solving, risk management, and decision-making skills.
Excellent collaboration and communication skills.
Attention to detail and significant data review experience.
Effective time management and multi-tasking skills.
Whats on Offer Competitive salaryand benefits package.
Opportunities for professional development and career growth.
A dynamic and collaborative work environment.
Exposure to cutting-edge technology and processesin the biotechnology and pharmaceutical industry.
Whats Next Apply now by clicking the Apply Now" button or call me, Ross Keyes, on.
If the job isnt quite right but you are looking for something similar, please get in touch.
We also have multiple Temp, FTC, and Contract jobs available.
Skills: CAPA Technical Transfer Benefits: Pension Bonus Life Assurance Permanent Health Insurance

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