דרושים Laboratory Support ב-West Pharma ב-Ireland, Waterford

Perform all required testing for routine testing and product release testing including water testing, environmental monitoring, endotoxin testing, BI processing and particulate testing. Support other laboratory functions as needed.

• Perform routine testing to support the plant functions including but not limited to environmental monitoring, water testing etc. Perform product release testing including, but not limited to, bacterial endotoxin, bioburden, testing, etc.
• Perform particulate testing in an ISO 5 lab on finished product.
• Perform incoming testing for materials, including growth promotion testing in culture media and incoming test for Biological indicators.
• Experience with working in an ISO clean room (Gowning and monitoring)
• Prepare and update Control forms, SOIs, and general lab documentation
• Prepare trends and technical reports based on data with guidance from lab management
• Participate in lab projects such as Method Transfers, Verifications, Validations and Equipment Qualifications
• Isolate and maintain cultures of bacteria or other microorganisms for future study.
• Support the Lab Supervisor and Lab Manager in internal, corporate and customer audits.
• Be willing and able to work as a team member to ensure continuous improvement relative to laboratory functions.
• Participate (or assist) in identification, investigation (OOS’s) and resolution of problems in the lab.
• Develop ability and competence with analytical techniques.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations and contribution to Improvement of Safety in the Laboratory.
• Compliance to all local site company policies, procedures and corporate policies.

• Degree in Microbiology, particulate testing, biology or science related discipline
• Graduate or individual with 1 - 3 years experience in a similar role (Microbiology/Particulate testing) within the pharmaceutical / medical devices / manufacturing industry.

• Good knowledge and understanding of principles of microbiological techniques
• Experience in a cGMP environment.
• Strong competence in IT - MS Office - Excel, Word and powerpoint.
• Good verbal and written communication skills
• Knowledge and Understanding of Particle Analysis and techniques an advantage but not essential

To support the maintenance and repair of Civil, Structural and Architectural of the buildings both internally and externally. Support external contractors for the maintenance and repair of same. The Maintenance Technician is also responsible for supporting the running and maintaining the preventative maintenance system to pre-determined guidelines.

• Responsible for the maintenance of all Facility equipment and plant systems (Utilities & HVAC systems) on site.
• Support commissioning/validation on existing and new projects.
• Support the scheduled maintenance as per Standard Operating Instructions.
• Filing and archiving of Facilities and Maintenance documentation.
• Communicate and update the Maintenance Dept. and other departments as necessary (e.g. compliance issues, investigation outcomes etc).
• Support in the management of maintenance contracts and contractors.
• Recording accurate hours against all planned work.
• Work with Engineering to identify maintenance strategy for all equipment.
• Ensure CMMS system users are fully trained and adhering to procedures.
• Work to identify opportunities for improvements.
• Work with Maintenance Engineer and Quality Engineers to ensure PM program is kept up to date.
• Work with Engineering to identify building, mechanical, and electrical spares to ensure maximum availability of equipment
• Support investigations to close deviations, change control and CAPA’s
• Responsible for compiling standard specifications & procedures for each item and monitoring all existing plant to standard specifications.
• Support production to ensure minimum equipment downtime through preventative and corrective maintenance.
• Respond to failed equipment or out of spec to meet production/batch release requirements.
• Plan equipment downtime with production and external vendors.
• Risk assess instruments through calibration classification.
• Understanding of P&ID, Electrical & Pneumatic Drawings

• Trade qualification in Construction/Mechanical/ Electrical /Instrumentation and or Diploma in Engineering, Electrical/ Process/Mechanical or building services engineering.

• Minimum 2 years’ hands on working experience preferably in a maintenance role within the pharmaceutical/medical devices/manufacturing industry.

• Familiarity using CMMS.
• Ability to interpret/design electrical schematics and to read hydraulic, pneumatic and P&ID drawings
• Previous experience working on technically challenging applications would be an advantage (i.e.) medical, tight tolerance work.
• Team player.
• Strong competence in IT
• Good verbal and written communication skills
• Excellent interpersonal skills with the ability to work with all levels within the organisation.
• Structured way of working & strong organisational skills
• Ability to interact with suppliers, customers and external contractors.

To support the maintenance and repair of Civil, Structural and Architectural of the buildings both internally and externally. Support external contractors for the maintenance and repair of same. The Maintenance Technician is also responsible for supporting the running and maintaining the preventative maintenance system to pre-determined guidelines.

• Responsible for the maintenance of all Facility equipment and plant systems (Utilities & HVAC systems) on site.
• Support commissioning/validation on existing and new projects.
• Support the scheduled maintenance as per Standard Operating Instructions.
• Filing and archiving of Facilities and Maintenance documentation.
• Communicate and update the Maintenance Dept. and other departments as necessary (e.g. compliance issues, investigation outcomes etc).
• Support in the management of maintenance contracts and contractors.
• Recording accurate hours against all planned work.
• Work with Engineering to identify maintenance strategy for all equipment.
• Ensure CMMS system users are fully trained and adhering to procedures.
• Work to identify opportunities for improvements.
• Work with Maintenance Engineer and Quality Engineers to ensure PM program is kept up to date.
• Work with Engineering to identify building, mechanical, and electrical spares to ensure maximum availability of equipment
• Support investigations to close deviations, change control and CAPA’s
• Responsible for compiling standard specifications & procedures for each item and monitoring all existing plant to standard specifications.
• Support production to ensure minimum equipment downtime through preventative and corrective maintenance.
• Respond to failed equipment or out of spec to meet production/batch release requirements.
• Plan equipment downtime with production and external vendors.
• Risk assess instruments through calibration classification.
• Understanding of P&ID, Electrical & Pneumatic Drawings

• Trade qualification in Construction/Mechanical/ Electrical /Instrumentation and or Diploma in Engineering, Electrical/ Process/Mechanical or building services engineering.

• Minimum 2 years’ hands on working experience preferably in a maintenance role within the pharmaceutical/medical devices/manufacturing industry.

• Familiarity using CMMS.
• Ability to interpret/design electrical schematics and to read hydraulic, pneumatic and P&ID drawings
• Previous experience working on technically challenging applications would be an advantage (i.e.) medical, tight tolerance work.
• Team player.
• Strong competence in IT
• Good verbal and written communication skills
• Excellent interpersonal skills with the ability to work with all levels within the organisation.
• Structured way of working & strong organisational skills
• Ability to interact with suppliers, customers and external contractors.

Provide day to day support for test preparation within the Waterford laboratories including local and global samples. Support the routine operation of the analytical laboratories by performing tasks such as test preparation, reagent preparation, housekeeping, sample management and stock management to ensure testing activities can be completed on time.

• Support preparation of reagents and solutions for use in testing as scheduled
• Preparation of samples for testing as scheduled
• Preparation and labelling of glassware for testing analysts as scheduled
• Routine Sampling to support testing (e.g., water sampling of plant systems)
• Verification of basic lab equipment as scheduled
• Calibration of basic equipment as scheduled
• Perform routine housekeeping activities as scheduled in the laboratories including processing of lab glassware and waste disposal as scheduled
• Support the movement of samples and bags from receipt to disposal as scheduled
• Support the shipment of samples externally as scheduled
• Support lab stock inventory management and place orders and process all chemical and consumable deliveries as scheduled
• Maintain sample receipt and laboratory areas to ensure sample management is clear and systematic
• Support monthly and weekly stock takes as scheduled and notifying departments when supplies are low
• Update and maintain laboratory procedures and control forms as scheduled
• Organization and reconciliation of lab paperwork as scheduled
• Implement and maintain continuous improvement activities (Lean, 6s) in the lab
• Attend meetings as requested by supervisor/manager
• Maintain cGMP and ISO compliance
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct
• Escalate concerns relating to sampling/laboratory issues in timely manner to supervisor/manager
• Compliance to all local site Environmental, Health and Safety regulations
• Compliance to all local site company policies, procedures and corporate policies
• Other duties as assigned

• Minimum Leaving Certificate or equivalent

• Experience in a Laboratory environment or cGMP/pharmaceutical environment is advantage but not required

• Excellent IT skills (MS Word, Excel, Outlook, PowerPoint) desirable
• Experience in a Laboratory environment or cGMP/pharmaceutical environment is advantage but not required
• Excellent organizational skills
• Strong verbal and written communication skills, Microsoft excel, word, power-point etc.,
• Strong attention to detail
• Ability to multitask, manage time efficiently and prioritize effectively across multiple labs.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

• The role is part of a Digital and Transformation (D&T) Team.
• The role will be primarily responsible for administrating, supporting and implementing lab instrument software within Analytical Labs focused on Waterford and other EU locations.
• Additional responsibilities will include working with sever based laboratory applications (LMS, SDMS and Empower) as needed.
• The Solutions Architect will work closely with other members of the D&T, QA, Metrology and Lab Operations to ensure these systems meet the needs defined by Global Analytical Services while maintainingapplicable regulatory requirements (i.e., cGMP, Computer System Validation, 21 CFR part 11 compliance).

• Administer and support lab equipment software within the Waterford Analytical Services to ensure systems are operational
• Work with server based lab applications such as LMS, SDMS and Empower which are directly integrated with the equipment as requested.
• Participate in the assigned activities which support the roll out of key initiatives for lab automation and compliance to the global site laboratories
• Participate in rotating “on-call” support to provide 24 hours/7 days/365 days per year application support. This includes coordinating support with the software vendors as needed.
• Maintain systems in a compliant environment to control costs, reduce risks and improve productivity
• Collaborate with Lab Operations and Metrology to ensure system needs within Analytical Services are communicated
• Write, execute IQs, OQs, PQs, and validation protocols as necessary
• Initiate and review documents such as change controls, CAPA's, laboratory investigations, work instructions, SOP’s, etc., as assigned
• Ensure that new systems and software are properly integrated with existing processes and capabilities
• Perform other tasks as assigned

• Bachelor’s degree or equivalent experience in IT, Laboratory systems or a Scientific field

• Minimum 3 years of experience of IT support and / or IT operations, ideally in regulatory manufacturing environment
• Minimum of one year experience working with Lab Systems
• Experiences in collaboration within international teams a plus

• Working knowledge of various analytical instruments software
• Experience working in cGMP compliant Analytical Lab with knowledge of Part 11 compliance and validation.
• Solid understand of PC Hardware, PC based networking and Microsoft Windows operating systems
• Ability to work with staff, peers, and others in a fast pasted, team oriented, cross functional, multi-cultural environment to accomplish established goals and objectives as well as identify and resolve problems.
• Shows initiative and ability to work independently
• Strong analytical, problem solving and decision making abilities
• Excellent written and verbal communication skills required.
• Working knowledge of any or all of the following applications Waters Nugenesis SDMS , Waters Empower, Laboratory Monitoring System such LMS Pharma a plus
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

• ITIL Foundations Certification, A+, COMP TIA, a plus.