Careers
Positions available at FPK
All interested candidates are welcome to submit their CV or contact us for more information. All CVs will be received in the strictest of confidence and will not be turned in for any suitable role without your permission.
Any person that works with FPK will be given the structure and support to achieve their career goals whilst ensuring work-life balance.
Please see list below of all open roles available at FPK. Press each role to open tab to get description of the role.
Description:
Our Clients site, located in the South East Region are excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment and to ensure compliance of equipment, systems and processes in sterile products manufacturing.
The successful candidates will support several aspects of Validation. The roles available that will require experienced, energetic and committed engineers are in the following areas:
1. Sterilisation – Autoclaves, SIP of vessels
2. Cleaning – Parts Washer and CIP of vessels
3. Isolator (Filling, Sterility & Material Transfer isolators) – HVAC, VHP, E-Beam and Depyrogenation systems
4. Controlled Temperature Units (CTU) – Temperature/Humidity Mapping
5. Filter Validation
In addition the role will include:
- Internally involved in the validation of all new equipment, processes and control systems.
- Generates Validation Documentation (protocol/reports) and provides assistance with the execution of protocols for equipment, and computerised systems.
- Participates in the change control process advising on validation issues, as appropriate.
Qualification Required:
Relevant technical qualification(s) in Applied Pharmaceutical/Biological/Chemical Sciences or applied Technical/Engineering Qualification, the successful candidate will also have a proven track record in delivering excellence.
Interested in role please submit CV below or email [email protected]
Description:
Our Clients site, located in the South East Region are excited to offer a fantastic QA/QIPT Specialist Role. This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment.
The team working style is one of collaboration, coaching and facilitation to ensure the success of the site. The Associate Specialist/ Specialist is accountable for the Quality Systems within the site.
Primary activities/responsibilities:
- Provides to the site knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/ Investigations/LIR coaching; GCM coaching, environmental monitoring program, sterility assurance/low bio-burden manufacturing, customer complaint investigations etc.
- Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
- Provides compliance contribution to project teams and leads small projects.
- May coach and guide colleagues within the site.
- Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
- Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
- Supports Corporate Quality to ensure actions related to Quality Systems and/or Operational Quality at the site are executed.
- Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
- Ensure supply of high quality product through the implementation and oversight of the Quality Management System for the site.
- Ensure the highest Quality, Compliance and Safety standards.
- The Associate Specialist/ Specialist will participate and comply with the Quality Management System (QMS) requirements, including ownership.
Qualification:
Degree or 3rd level qualification (Science, Quality)
Interested in role please submit CV below or email [email protected]
Description:
Our Clients site, located in the South are excited to offer a fantastic opportunity in Cleaning Validation.
- Execute cleaning cycle development and PQ of equipment.
- Writing and adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
- Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
- Provide support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards.
- Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
- Technical report writing, statistical analysis of data
- Adherence to the latest regulatory guidelines.
- Represent the IPT on cross-functional project teams.
- Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
- Adherence to highest standards for Compliance (Quality and Safety)
- Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.
- Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
Qualification:
Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or a related field.
Interested in role please submit CV below or email [email protected]
Description:
Our Clients site, located in the South East Region are excited to offer a fantastic opportunity in the digital team as part of the IAT Network Upgrade. Who will assist in implementing and driving effective usage of Digital Solutions and Industrial standards in the areas of application systems and digital Products.
• Respond to user requests for service, troubleshoot problems and help develop solutions. • Support PC hardware components, desktop operating system software, and application software.
• Perform minor repairs to equipment and arrange for other servicing needs. • Identify and report system issues. Monitor and test resolution of issues.
• Record activities, solutions, and other responses to request for service.
• Assist in maintaining inventory records and documentation for equipment.
• Contribute to Sanofi IT documentation and participate in policy, procedure, and standards development.
• Assist users in determining appropriate software solutions to meet needs.
• Support in the definition and execution of IT asset management.
• Develop and provide user training for basic hardware and software use.
• Provide technical support for VC rooms.
• Process user support requests and take measures to fulfil requests.
• Support the IT Digital team in maintaining hardware, software, and other systems.
• Assist with troubleshooting issues and provide technical support.
• Contribute to introduction and adoption of new IT tools within the company
• Setting up new computers, networks, and software for new employees
• Updating team documentation
• Support our site Digital Transformation project
• Perform other duties/projects as assigned.
• Maintains open communication and positive working relationship with staff. • Work in a dynamic team-based environment
Qualification:
• Proficiency in common IT Applications (Office, etc.)
• Basic understanding of computer networking
• Ability to work well in teams
• Strong work ethic and attention to detail
• Ability to prioritise tasks and efficiently manage time
• Strong communication, customer orientation and ongoing engagement skills
• Ability to keep calm, confident and focused when working under pressure and time deadlines
• Resourceful and innovative
• Value diversity and integrity
Interested in role please submit CV below or email [email protected]
Description:
Our Clients site, located in the South East Region are excited to offer a fantastic opportunity as a Maintenance Technician.
Responsible for maintaining and troubleshooting process devices, instrumentation and controls in support of vaccine manufacturing. Ensure that objectives are effectively achieved, consistent with the client’s requirements to ensure compliance, safety and reliable supply to our customers. The Maintenance Technician will collaborate across functions, supporting, the project sub-teams maintenance requirements. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable to the clients standards for Quality and EHS compliance.
Qualification:
- Leaving Certificate or equivalent required
- Time serviced Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline is required
Note: Senior Roles available
Interested in role please submit CV below or email [email protected]
Description:
We have multiple Clients sites, located in the South / South East Region and are excited to offer a fantastic opportunity as project engineer to deliver a diverse project portfolio.
Delivery of this project portfolio will be within our client’s biopharmaceutical operations which include enzyme, monoclonal antibodies (mAbs), oral dosage, medical device, laboratories & packaging operations. The project portfolio will cover Equipment based & Facility based , life cycle management ,Energy and carbon reduction programs.
The successful candidate will schedule, plan, forecast, resource and manage all activities to ensure the project schedule, cost, quality and scope adherence are maintained from conception to completion.
The assigned projects will be for a multi-million-euro portfolio ranging.
Qualification:
• Degree in Electrical , Mechanical, Chemical, Industrial or equivalent Engineering discipline.
• Minimum 5+ years’ experience in a project management role.
• Detailed knowledge of cGMP pharmaceutical environment.
• Exemplary communication, dedication and keen focus on delivering key to success withing the role.
• Masters an advantage
Note: Junior roles also available.
Interested in role please submit CV below or email [email protected]
Description:
Our Clients site, located in the South East Region are excited to offer a fantastic opportunity in Utilities as Critical Utilities Specialist.
- Development, review and approval of technical information including Safety Risk Assessments, Work Plans, Commissioning documents and CMMS data.
- Establish Equipment Criticality and apply appropriate reliability and asset management strategy based on criticality
- Ensure compliance to all Safety, regulatory GMP and Environmental requirements.
- Working with technicians and other functions to develop Prescriptive, Predictive and Preventative maintenance program to ensure designated site equipment operate safe and reliable. Optimise work tasks, ensure spare parts, tools or other services are available when required.
- Investigate equipment failures or deviations to find root cause and implement effective Corrective and Preventative Actions.
- Provide technical training to colleagues.
- Develop and manage KPI’s – ie People, Safety, Quality, Delivery and Cost performance.
- Support Engineering Excellence Initiatives – participate in local and corporate programs.
- Pursues and use new technologies and methodologies.
- Own the initiation, management and closure of change initiatives.
- Schedule vendor visits for Planned and reactive maintenance works.
- Escalation point for Utilities equipment issues.
Qualification:
- Knowledgeable of mechanical, electrical, control and automation systems maintenance requirements.
- Experience of writing Operating Procedures.
- Experience in root cause analysis and writing GMP deviation investigations.
- Experience of continuous improvement and maintenance optimisation techniques.
- Some experience of data analytics, reviewing of trends and development and management of alerts.
- Working knowledge of SAP or another Maintenance Management System.
- Knowledge and Experience of Utilities Safety requirements, Statutory Inspections and Contractor Management
Interested in role please submit CV below or email [email protected]
Description:
We have multiple Clients on multiple sites, located in the South / South-East Region are excited to offer a fantastic opportunity in Project Management as Project Manager.
- Leads the Global Engineering Solutions outsource team at the Carlow site in conjunction with chosen partner company.
- Leads the capital program efforts for new product introductions in conjunction with site
- Acts as GES representative at the site Engineering Tier 2 fo
- Takes GES responsibility for and oversight of the preparation of individual project Business Case, Concept Design Packages (CDP’s), Basis of Design (BOD) documents, Cost Estimates and Schedules, and presentation for approval by appropriate plant or divisional management, ensuring that capital installations are delivered in a cost effective manner that meet Safety, Environmental, GMP and Financial requirements.
- Responsible for quality and safety compliance within the GES Team on
- Responsible for working with the OEP EPCM on team resource management – aligns on headcount required, disciplines and reviews proposed resources for onboarding into the tea
- Leads GES Shutdown Preparations in conjunction with the chosen EPCM’s for various projects and co-ordinates with site shutdown team and stakeholders on preparations e.g.: power outage co-ordination, fortnightly meetings.
- Acts as Day to Day OEP point of contact for EPCM OEP Lead.
Qualification:
- Project Management
- Team Leadership
- Process and Equipment design
- Financial Management
- Process Operations
- Process, equipment, cleaning Validation
- Environmental policies and procedures
- Safety policies and procedures
- Training policies and procedures
- Quality policies and procedures
- Engineering Department policies and procedures
- Financial Management
- Analytical Skills
- Decision making
Interested in role please submit CV below or email [email protected]
Description:
Our Clients site, located in the South East Region are excited to offer a fantastic opportunity as Senior QP, who is looking for you to join their expanding team who will provide leadership and development to the QP team and QA staff.
- QA Oversight of (specifically of API/DP operations) in the production facility.
- Management of batch disposition and material status control activities associated with, acting as a site Qualified Person.
- Management of review of Batch Manufacturing Records (BMRs).
Management of QA oversight of routine manufacturing, testing and relating activities to ensure ongoing cGMP compliance. - Implementation of KPIs within the Quality Assurance area to align with company and global quality objectives.
- Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
- Motivation, training, discipline and appraisal of Quality Assurance staff.
Qualification:
- Bachelors Degree in a Science or related discipline.
- Qualified Person status, as per EU Directive 2001/83/EC.
- 2-3 years’ experience working as a Qualified Person, with minimum of 5 years’ QA experience in the pharma industry.
- Experience of oral solid dosage manufacture.
- Excellent knowledge of GMP as described in current FDA & EMEA regulations for oral solid dosage pharma manufacture.
- Excellent verbal and written communication skills.
- Strong project management and organisational skills.
- Ability to adapt to changing priorities.
- People management experience is desirable but not essential.
Interested in role please submit CV below or email [email protected]
Description:
Are you an experienced Building Services Engineer with experience of managing and executing projects from concept design through to commissioning?
We have a fantastic opportunity for an ambitious Building Services Design Engineer to join our growing team based in Kilkenny, with a hybrid working option available for the right candidate.
This role will require leading various design stages of projects from concept to detailed design on multiple projects within the Pharmaceutical and Medical Devices industry. The successful candidate will report functionally to the Department Manager and on a project basis to the Lead Design Engineer or Project Manager.
Qualification:
- Third Level Degree in Building Services, Mechanical Engineering or similar discipline (5yrs+ Experience)
Interested in role please submit CV below or email [email protected]
Submit your CV to apply for one of these available positions or visit our LinkedIn page