Validation Engineer

Crest Solutions are seeking a Validation Engineer to join our team and work on our customer site in Cork.

What We Do:

Crest Solutions are an engineering and software company that supply and support the resourcing of engineers, analysts, specialists and other professionals in this field. We are home to a vibrant group of professionals, working together to deliver to our clients. As a Gold Certificated company in the NSAI Excellence Through People scheme, Crest Solutions strives to guide many of Ireland’s most successful organisations to become more efficient, productive, flexible, competitive and innovative, through the development of great people.

Reporting to the CQV Lead (part of the Capital Projects Team) A CQV Engineer is required to work predominately with a new/ existing Vial Filling Lines to accommodate increasing the site capacity. The CQV engineer will be required to work together a multidisciplinary team (Project Manager, Automation, QC/QA, Process Engineering, maintenance etc) across all stages of qualification from design through to commercial batches, support all CQV activities

Responsibilities and Tasks:

• The chosen candidate would typically be accountable for the following activities (but not exclusively);

• Review and approve vendor/field Turnover packs for all aspects of the project

• Review, approve and execute FAT, SAT to support qualification stages

• Develop, execute, review and approve of installation, operational and performance verification protocols (IQ, OQ, PQ) ensuring that all issues identified during execution are managed correctly, efficiently and in accordance to site procedures.

• Support the schedule of qualification activities.

• Provide technical oversight and guidance to resolve issues has they arise, and any design aspects required.

• Escalate issues that could result in a delay to the commissioning/ qualification schedule

• Work collaboratively with project support groups (e.g. automation, construction, engineering, end user, quality) and their management to influence decisions

• Knowledge of up-to-date regulations and guidelines (ICH, ASTM, FDA, ISPE) and modern CQV practices.

• Manage and report on their workload and progress weekly to the CQV Lead and escalate any issues that will cause a delay to project timelines.

• Coordinate with and assist other C and Q activities as needed to facilitate completion of C and Q work.

• Abide by all safety requirements and procedures pertaining to their role; serve as a positive model to others in this regard.

• DISCLAIMER: This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the job. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned.

  
  

  PRINCIPAL QUALIFICATIONS/SKILLS & EXPERIENCE REQUIRED:

• BSc in Engineering or life Sciences (or equivalent experience)

• 7 + years’ experience in validation engineering in Biotech/Pharmaceutical industry supporting manufacturing (quality, process development, manufacturing, & clinical manufacturing).

• Previous experience with vial or syringe filling lines, vision systems, product transfer methods (PCS) single use technology & SCADA

• Experience in sterility aspects for a RWM (washer) and Dehydrogenation tunnel would be an advantage, along with commissioning and qualification knowledge of supporting utilities required i.e. WFI a, Clean AIR, Compressed Air

• Experience in executing engineering projects in a fast-paced dynamic environment

• Excellent verbal and written communication skills with both technical and non-technical staff

• Strong analytical problem-solving skills.

• The candidate will have knowledge and proficiency in the use of analysis tools, continuous improvement methodologies, problem solving and applied engineering relating to control systems

Why Join Crest Solutions?

At Crest Solutions we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Crest Solutions benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities. An example of what is offered to our team members is as follows: 

• Competitive salary.

• Full healthcare cover, leave benefits, life assurance, flexi-time and pension scheme.

• A varied and exciting career with Crest Solutions with opportunities to work in a cutting-edge, innovative technological environment.

• A structured approach to professional development opportunities with an educational assistance program.