Jack Steadman

QC Microbiology Specialist – Dublin – Pharmaceuticals – 11-month contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a QC Microbiology Specialist. What you’ll do: Perform and support QC analytical activities including in-process, release and stability related testing.Provide day to day direction and scheduling to the QC analyst team.Responsible for the qualification, maintenance, and/or integration of the QC methods, in compliance with up-to-date data integrity, regulatory, and industry standards.Responsible for driving a culture of Continuous Improvement.Ensure that cGMP standards are maintained at all times.Accountable for change control process and mechanisms required to maintain a state of continued compliance for the methods.Manage deviations, CAPAs and change controls. What you’ll need: Industry experience with significant knowledge and experience working in a Microbiology Laboratory in a pharmaceutical companyExperienced in testing as per the pharmacopeia’sWorking knowledge of QC Digital Systems (eLogs, Electronic Lab Notebook, LIMS etc.)Ability to respond to changing prioritiesStrong organisational skills If this role is of interest to you, please apply now! #LI-JS5

Electrical Engineer - Ireland, Limerick - 12 Month Contract Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the World. An exciting opportunity has arisen to work for a global pharmaceutical organisation on a major expansion project based in the picturesque Limerick. Essential Duties and Responsibilities for this role include, but are not limited to, the following: Design and Maintenance of LV (e.g., Lighting, General Services, UPS, Protection Settings incl. Arc Flash) and ELV (e.g., Fire Alarm, Data points, Building Automation) systems. Manages small projects related to electrical systems infrastructure. Assists in the design review, site acceptance, and installation of electrical equipment. Prepare and maintain electrical drawings and related documentation.  Desirable Experience: Bachelor’s degree in electrical engineering.Requires extensive experience in a relevant field. If this role is of interest to you, please apply now! #LI-JS5

Operations Specialist - Ireland, Dublin - 11 Month ContractDo you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require an Operations Specialist. Essential Duties and Responsibilities for this role include, but are not limited to, the following: Lead/Guide team members within the Production Operations teamCoach and develop colleagues within the Production teamSupport team on shift cycle and act as POC (point of contact) and POE (point of escalation) to ensure effective issue resolution Lead, facilitate and participate in cross-functional teams to collaborate effectively to cover compliance topics.  Desirable Experience: Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering. Extensive experience in Biotech Industry.Position level will scale with experience level of candidate. Competent in analysing complex situations and show practical problem-solving capabilities. Ability to work independently and within a cross-functional team. Understanding of multi column chromatography concepts Familiarity with contamination control and batch release requirements Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits  If this role is of interest to you, please apply now!#LI-JS5

MS&T Process Engineer - Ireland, Dublin - 11 Months Initial Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a MS&T Process Engineer. Essential Duties and Responsibilities for this role include, but are not limited to, the following: Demonstrated leadership and change management skills with a continuous improvement focus.Proven track record of delivering high performance through development and coaching of a team.Evidence of continuous professional development.Strong collaboration to promote knowledge sharing and implementation of best practices across the site.SME in upstream/downstream processing and process control strategies. Working knowledge of analytics.Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment. Desirable Experience: Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualificationExperience leading technical related projects.Experience with upstream cell culture and/or downstream purification of biological molecules.Experience in preparing for and presenting in front of regulatory audits as SME.Experience with technology transfer, regulatory filing and commercial drug substance manufacturing of biologics is a plus.Technical operations experience in the drug substance manufacture of biological molecules at commercial-scale.Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.Experience in change management, deviations and CAPAs management. If this role is of interest to you, please apply now!#LI-JS5

Quality Specialist - Ireland, Waterford - 11 Months Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Quality Specialist. Essential Duties and Responsibilities for this role include, but are not limited to, the following: Includes participating in and supporting the site PVC (Process Validation Committee), WVC (Water Validation Committee), CVG (Cleaning Validation Group),) and Equipment Qualification Validation Committee (EQVC).Approval of all validation documentation and ensuring compliance to MMD policies, procedures and guidelines. Ensures that validation status is maintained following changes/modifications.Supports the implementation of site or capital projects by defining validation requirements and providing technical assistance and support as a member of the project teams.Develops Validation Summary Reports and assist in developing overall Quality plans for major projects.Works with other areas in MMD and industry to predict future trends in validation and to determine best practice. Desirable Experience: The incumbent must be assertive with excellent communication skillsExperience with QMS SystemsQuality Assurance/Quality SpecialistStrong Communication skills both written and oral including persuading others If this role is of interest to you, please apply now!#LI-JS5

Technical Specialist - Ireland, Cork - 11/12 Month Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Technical Specialist.The site has received €130 million in investment over the last five years to continue the growth and expansion of the facility; with new products coming to the site, it is an exciting time to join the team. Essential Duties and Responsibilities for this role include, but are not limited to, the following: Support department and site level activities that require process and operational knowledge. Support process operations including trouble shooting technical and process related issues and leading investigations utilising MPS principles i.e. DMAIC/A3/OPPS etc.Managing EHS and Quality investigations, coaching, completing and overseeing batch record reviews.Lead cross-functional Technical Projects to further develop the Vaccine Process. Desirable Experience: Hon. Degree or Masters in a Science or Engineering discipline (Preferably Biotechnology).  Extensive experience in biopharmaceutical/vaccines environment. Knowledge in material management and associated systems. Direct experience with Single Use Technology i.e. operational use, problem solving, vendor engagement. If this role is of interest to you, please apply now!#LI-JS5

EHS Specialist - Ireland, Dublin - 11 Month Initial Contract This is a fantastic opportunity to be part of a fast-paced, €400 million project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.  When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a EHS Specialist. Essential Duties and Responsibilities for this role include, but are not limited to, the following: Be the EHS point of contact and the owner of numerous cross site local EHS standards and complete EHS gap assessments and audits of effective EHS standards in line with Global Safety and Environment Standards. Special emphasis is paid to standards on Industrial Hygiene, Biosafety, Chemical Management, and Process Safety Management.Compile and submit required safety, health, and environmental reports to corporate and regulatory agencies.Assist with managing contractor EHS compliance and related high-risk work HRW safety procedures to a high-performance level.Ensure that Pre-Start Up, Safety, Environment Review (PSSER) for new product introductions within the facilities are compliant with regulations, corporate requirements and industry best practices. Desirable Experience: Ability to manage complex programs and to balance the strategic needs of the program Extensive EHS experience in Pharmaceutical / Biotechnology / Chemical industries. Will consider other highly regulated industries.Experience in successfully implementing EHS programs enterprise wide.Experience in managing and implementing change  If this role is of interest to you, please apply now!#LI-JS5