Job Description:

Multiple CQV contractors required for large multinational expansion projects in Copenhagen, Denmark.

Experience in CQV if API and utilities is desirable. The roles come with excellent rates and low ex-pat tax available.

Roles available to suite experienced (10+ years), intermediate (3+ years) and Graduate (with placement or other experience) levels.

Job Description:

Deliver Operational Readiness and Aseptic Excellence throughout Form / Fill Finish activities.

Lead the Process Simulation development and execution

Work on continuous improvement initiatives and troubleshooting activities

Requirements

Degree or equivalent + extensive operational experience within high speed aseptic filling lines and formulations areas in aseptic manufacturing environments.

Proven Leadership capability, strong influencing skills and ability to work cross-functionally

Technical expertise in Aseptic Techniques and Form / Fill Finish

Job Description:

Contract QAV professional required, Degree + 5 years QAV experience required.

Duties include review of validation protocols, validation reports, change control oversight and review, deviation/ CAPA review. Can work independently and as part of a team .

Please submit your CV for consideration

Job Description:

Technical Engineering role to deliver on the Tech Engineering requirements needed to support Tech Transfer, Validation programs & strategies, Technical support and process improvement projects, network support & collaboration.

To lead and execute process engineering and validation activities to support the technical transfers as well as sustaining site validation activities such as requalifications, annual reviews etc

Act as a subject matter expert on (1) Equipment Design & qualification; (2) Assisting in C&Q execution and planning; (3) Process design and validation

Act as a liaison with both global engineering services and facilities as well as specialist vendors on process requirements to deliver projects

Continuous improvement and experience with facility commissioning and startup an advantage

Please submit your CV for consideration

Job Description:

Multiple QC Sample Management Shift roles open for a Pharmaceutical client in North Dublin, Ireland.

Please submit your CV for consideration

Job Description:

The HVAC Validation Engineer will perform an integral role in the development of the drug product facility; provide leadership, cross functional support and technical expertise to IUFT (Integrated Utilites Facilities Team), maintenance and manage their operation.

Candidate Requirements:

• Degree qualification or equivalent (Science, Engineering, Technical).
• SME (subject matter expert) in HVAC/Refrigeration engineering lifecycle – design, through to sustaining operations
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Lean Six Sigma Methodology experience desired

Job Description:

Multiple Process and Equipment Engineers required for a Pharmaceutical client in South Dublin, Ireland.

Please submit your CV for consideration

Job Description:

QC Micro Analyst required for a Pharmaceutical client in North Dublin, Ireland.

Please submit your CV for consideration

Job Description:

Multiple QCSM roles open for a Pharmaceutical client in South Dublin, Ireland.

Required: Degree or equivalent, 2-3+ yrs Sample Mgmt/Stability exp, GMP
Keywords: Sample Management, Stability Programme, QC, LIMS, Sample Plans

Please submit your CV for consideration

Job Description:

QC Analyst required for a Pharmaceutical client in North Dublin, Ireland.

Please submit your CV for consideration

Job Description:

Multiple Manufacturing Process Technician – Inspection/Packaging (Shift/FTC) open in South Dublin

Please submit your CV and we can then determine the most appropriate level and area for your skills & preferences.

Job Description:

Multiple QA Specialist roles open for a Pharmaceutical client in Waterford, Ireland.

Roles are at various levels depending on experience. Openings are in the following areas: Fill Finish/ Packaging/ PFS/ Med Device/ Labs.

GMP/ GLP experience required for all role levels. Sterile experience is required for some but not all roles. Certain roles are days only while others are shift with shift premiums.

Please submit your CV and we can then determine the most appropriate QA Specialist level and area for your skills & preferences.

Job Description:

Candidate requires Degree or Diploma with one year minimum microbiology experience. Validation experience also desired for this role. This new site offers the opportunity to work on multi projects with extensive career development opportunity. Please contact us for further details.

Candidate Requirements:

• Life Science Degree
• Min. 8 years GMP Biopharma, supervisory/ mgt experience required
• Extensive experience in validation
• Audit experience (in-house, customer & regulatory)
• Supervisory/ Management Biopharma experience

The Engineer will take ownership for the operation and maintenance of the new state of the art drug product facility.

Provide leadership, cross functional support and technical expertise to IUFT(integrated Utilities Facilities Team), maintenance and manage their operation through design, construction, validation, start-up and commercial manufacturing.

The Facilities Engineer will collaborate across functions, supporting, coaching and facilitating project sub-teams.

Requirements:

• Degree qualification or equivalent (Science, Engineering, Technical).
• SME (subject matter expert) in Facility management (design, through to sustaining operations; including ARM – asset reliability maintenance).
• SME in Facilities (Facility Maintenance, NGMP cleaning, GMP cleaning, Pest Control, Building Maintenance, Breakrooms/Canteen, Landscaping, Warehouse Equipment (Racking/Forktrucks), Laundry/Garbing/Lockers, Security, Waste and Temp. builds/offsite storage).
• Lead, promote, participate and supervise the implementation and maintenance of the relevant safety programmes.
• Delivery of safety, performance and quality goals.

2 Principal Scientists are required to join the Method Development Validation Team and their Molecular Cell Biology Team in Dungarvan. 

This person will be responsible for leading a team to establish a wide range of new service offerings in Biopharmaceutical test area as well as performing a wide range of assays to support current client projects. 

Experience with analytical development; validation and data interpretation is required.  All work is performed in a GMP environment.  The position will involve client contact as well as the ability to lead client specific and internal projects to a successful conclusion.

Requirements:

• Master’s degree in biochemistry/analytical chemistry with a minimum 6 years’ experience is desirable.  PhD or proven scientific writing to a publication standard is desirable.
• Method Development Validation Principal Scientist: extensive knowledge of Bioanalytics, HPLC, CE, ICE is required.
• Molecular Cell Biology Principal Scientist: extensive knowledge of Molecular Cell, ELISA, Cell Assay
• Good team player, organised, accurate, have strong documentation skills.

Job Description:

C&Q Engineers will be responsible for commissioning and qualification of new build Drug Substance facility

Candidates must have demonstrated experience in working to tight project deadlines while adhering to GMP standards.

Skills of interest:

• Start-up project experience
• Bioprocess equipment backgrounds
• Utilities experience
• Bioreactors experience
• Buffer Prep/Media Prep knowledge
• Chromatography column/skids knowledge

Responsible for the manufacturing area instrumentation calibration program, troubleshooting of process equipment issues and the review and approval of equipment calibration documentation.

Ensure that all calibration requirements are met in compliance with site and regional requirements to ensure regulatory compliance, safety and a reliable supply to customers.

The Electrical & Instrumentation (E&I) Engineer will perform an integral role in the development of the drug product facility.

Requirements:

• Bachelors Degree or equivalent; ideally in a related Science, Engineering or other Technical discipline.
• Minimum of 5 years relevant experience in Electrical & Instrumentation engineer / engineering role within a maintenance / engineering org of manufacturing facility (preferably GMP)
• Demonstrated experience in process instrumentation/equipment and in-dept knowledge of calibration methods.

The primary purpose of this role is to execute the Validation schedule and helpdesk activity required to support the Operations function at ELL, operating at the highest quality and productivity standards, ensuring agreed internal client requirements are entirely satisfied and that client expectations are met or exceeded.  This person will be a key point of contact for all Validation activities on a day-to-day basis, including external audits.

Requirements:

• Primary degree or equivalent in related discipline (Life Sciences, engineering)
• At least 1-5 years’ experience in a laboratory or GMP regulated environment is desirable; preferably with Calibration/Validation experience.
• Experience in IOPQ & understanding on GAMP for Lab equipment would be desirable

We offer both consulting and staff roles with Mitto Consulting. Consultancy roles involve providing your Biopharma expertise directly to our clients. Staff roles with Helio Consultancy can involve a mix of off site (at our offices/ remote work) and on site support.

While our focus is on the Biopharma industry, we also can provide services to Life Sciences, Medical Devices, Oil & Gas, Renewables industries.

Once we receive your CV, we will review current and upcoming job opportunities to see if we can match your skills and experience with the right role for you. We will keep you informed on the latest cutting-edge projects.

That depends on roles available and project demands. We try to give job seekers as much notice as possible on upcoming relevant roles to them. Some requirements are ASAP depending on the clients project status.

Simplest way to find out is send us your CV and we will let you know if you have the appropriate expertise and experience. We can also discuss your aspirations and let you know about upcoming roles, either now or in the future, that may appeal to you.

Mitto Consulting never charges fees to candidates. All fees are paid by the client company.

Yes of course. We will help you get organised as soon as possible so that you can relax and look forward to your journey ahead

Yes, see referral form above. Please contact us for details.