Validation Specialist – Cell and Gene Therapy

Validation Specialist – Cell and Gene Therapy

Validation Specialist – Cell and Gene Therapy

Galway, Ireland | Permanent full-time role & flexible working conditions

HiTech Health focuses on enabling healthcare companies to develop, launch and supply products to the market. The company was established in 2013 in Dublin, Ireland, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports healthcare companies globally from the development to the launch and supply of products.

This is an exciting role for a highly motivated individual to join a growing organisation and be deeply involved in leading validation activities, to work as a Validation Specialist for our expanding laboratories in Galway.The candidate will work closely with clients and other functional units within Hitech Health including production to support the development and manufacture of a range of cell and gene therapy products, as well playing a key role in the growth of HiTech Health.

Responsibilities:

  • Responsible for leading and executing Qualification and validation activities in a cGMP environment for key site processes, equipment and utilities and on-going process validation, in line with current regulatory requirements, corporate policies and site procedures (as per Validation Master Plans), including the generation/review of validation documentation (schedules/Risk Assessments/Protocols /Reports/Annual Reports/).
  • Presenting executed qualifications during internal and external audits.
  • Ensuring that a continuous state of validation is maintained for site equipment, systems and utilities, including providing validation input for site Change Controls.
  • Responsible for executing site periodic reviews and revalidation activities.
  • Accountable for writing, executing & reporting of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments).
  • Participate in project teams and assist in determining project schedules and the appropriate levels of validation.
  • Support the development of the quality plans for ensuring all regulatory requirements are met during the validation of equipment, facilities, utilities, or systems.
  • Ensure technical input and guidance on deviation investigations during qualification/validation activities in case of relevance or impact.
  • Provide support to the local organization as validation SME and as a primary Point-of-Contact for the relevant Regulatory Agencies on occasion of Regulatory Inspections, Customer audits and for the relevant follow-up.
  • Write and/or review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols).
  • Lead and/or participate in quality risk assessments.
  • Assist in the investigation and closure of deviations and Out of Specification investigations.
  • Ensure non-conformances/deviations are investigated and assessed for root cause and identification and closure of effective CAPA’s.
  • To participate in inspections by third parties, e.g. HPRA, FDA, customers, etc.,

Essential Requirements:

  • Minimum of a bachelor’s degree in science, Engineering, Technology or a related discipline.
  • Relevant experience as a validation specialist in a cGMP environment (3+ years).
  • Full understanding of cGMP requirements including Annex 11 and Annex 15.
  • Effective technical writing skills.
  • Experience of working in an aseptic manufacturing environment is desirable.
  • Good problem solving and investigation skills.
  • Ability to work under pressure and meet deadlines.
  • Highly motivated self-starter and team worker.
  • Good organisational, coordination and communication skills and demonstrates good attention to detail.
  • Rights to work full time in Ireland.

Salary Range: Negotiable. Salary is commensurate with experience and qualifications for this key position.

Working hours: Working hours will be 9 AM-5.30 PM daily. The nature of the work may require flexibility in working times.

To Apply: Applications to include a cover letter, CV, and the contact details of two referees should be sent, via e-mail (in word or PDF only) to recruitment@hrduo.com and info@hitech-health.com

Recent News

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for 'disruptive' project   HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...

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Head of Business Development – Cell and Gene Therapy

Head of Business Development – Cell and Gene Therapy

Head of Business Development – Cell and Gene Therapy

Ireland | Permanent full-time role & flexible working conditions

HiTech Health focuses on enabling healthcare companies to develop, launch and supply products to the market. Operating internationally, HiTech Health supports healthcare companies globally from development to launch and supply of new therapies with a focus on the manufacture, quality assurance and supply of these products.

This is an exciting role for a dynamic and determined individual to join a growing organisation, working as a Head of Business Development (BD) to drive sales in  our Cell and Gene Therapy business. We are seeking for a BD lead to drive our Cell and Gene Therapy CDMO business development, playing a key role in the growth of HiTech Health.

 

Responsibilities:

  • Develop a cGMP cell and gene therapy development and manufacturing customer base.
  • Support lead generation activities specifically in cell and gene therapy commercial organisations, research institutions/academic leaders.
  • Engage clients at biotech trade events, networking events and becomes active participants in key associations (e.g., BIO, ARM, etc).
  • Facilitate site visits for advanced client discussions and/or audit purposes.
  • Assist with proposals with technical teams in the overall process for:
    • Proposal generation and communications with prospects
    • Contract negotiation
    • Provide management with reports on Business Development activities
  • Deliver and onboard new clients to enable growth of business.
  • Lead business discussions with potential clients.
  • Establish and maintain contact with decision-makers and influencers within companies.
  • Expand HiTech Health’s Cell & Gene Therapy’s brand awareness.
  • Maintain relationships with key individuals in the industry and have extensive and up to date knowledge of industry trends and key collaborations and partnerships.
  • Set up and manage target territories through the use of the company’s Customer Relationship Management (CRM) tool and provide forecast reporting to management on a routine basis.
  • Accountable for meeting/exceeding performance metrics including revenue goals.

 

Essential Requirements:

  • Relevant four-year degree, Masters or PhD in a science/engineering field.
  • 5 years experience in biologics or cell and gene therapy CDMO/CMO preferred or extensive experience in highly regulated biotech/biopharma business development/sales organisation.
  • Effective communication, interpersonal skills and a positive attitude required.
  • Experience with solution selling in a multi stakeholder environment.
  • Ability to work collaboratively across the organisation including sales, service, technical support, marketing, and business management functions.
  • Must be highly motivated and able to work independently.
  • Demonstrate strong entrepreneurial mindset and good negotiating skills.
  • Attention to detail in all job functions and demonstrate high level of integrity.
  • Anticipate problems and remove obstacles to perform tasks as assigned.
  • Work to specific measurable objectives requiring operational planning skills.

 

Salary Range: Negotiable. Salary is commensurate with experience and qualifications for this key position.

Working hours: Working hours will be 9am-5.30pm daily. The nature of the work may require flexibility in working times.

To Apply:

Applications to include a cover letter, CV, and the contact details of two referees should be sent, via e-mail (in word or PDF only) to  recruitment@hrduo.com  and info@hitech-health.com

 

Recent News

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for 'disruptive' project   HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...

Stay Up To Date

Connect with us to receive the latest HiTech Health and industry updates.

Cell and Gene at the Abbey 2021 – Galway, Ireland

Cell and Gene at the Abbey 2021 – Galway, Ireland

From 10th to 12th November, HiTech Health hosted ‘Cell and Gene at the Abbey’, a world-leading conference focusing on Production, Scale-up and Globalisation of cell and gene therapies. We would like to sincerely thank all the speakers, sponsors and attendees of this year’s conference and are already looking forward to hosting the event in 2022.

Over the course of 3 days at the beautiful setting of the Glenlo Abbey in Galway, there were amazing insights from global leaders in the cell and gene therapy space. Overcoming production and supply chain challenges was a key focus with speakers from around the world attending the event. The exciting list of speakers included Power List 2020 in Advanced Medicines featured experts Bruce Levine, Massimo Dominici and Qasim Rafiq who spoke about development and regulatory approvals, challenges in scaling up, supply chain and manufacturing and the opportunities to solve them. An update on the European regulatory environment for Advanced Medicines from Niamh Curran of the HPRA was of benefit to all.

Attendees were able to see first-hand some of the latest technologies in cell processing technologies from many of  the event’s sponsors Cellexus, ChemoMetec, Miltenyi Biotec, Sexton Biotechnologies, Terumo, VivaBioCel, AccuScience and MeiraGTx. Cell and Gene therapies are at the forefront of regenerative medicine and HiTech Health are continuing to grow rapidly in this sector. Find out how we can support you on your development and commercialisation journey by contacting us today.