Are you a Manufacturing Engineer with strong problem solving & validation skills? This could be the perfect role for you!

This company is a leader in medical devices spaces based in county Waterford!

Job responsibilities:

• Designing manufacturing processes, procedures, and production layouts. 
• Developing manufacturing processes and measurement systems.
• Developing relevant work instructions and SOP’s and provides guidance to operations on training.
• Providing guidance to operations regarding design concepts and specification requirements.
• Ensuring processes and procedures are in compliance with regulations.
• Delivering and managing projects within an agreed schedule.
• Working with internal and external customers and partners to deliver on projects.
• Utilizing LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement.
• Writing and executing process and equipment validations (IQ/OQ/PQ).

Job Skills & Experience:

• 3rd Level Engineering Degree with a good hands-on working knowledge of medical device assembly.
• 4+ years of relevant experience in a highly regulated environment, 
• Proven track record in the execution of protocols and validations to regulatory requirements.
• Successful track record of project managing validation activities and cost reduction projects.
• Technical knowledge of Automated Systems (Pneumatic, Electro-pneumatic, Robotic)
• LEAN, Six Sigma experience
• Monitoring of materials, equipment and process flows during validation and ramp-up related activities to ensure high levels of performance and OEE.
• Process background (development, capability, optimization, validation) within a regulated industry.

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Role Purpose

• Under limited supervision, participates as a team member in qualification/validation activities related to laboratory instrument/equipment systems including computer systems.
• The position additionally provides lead duties by providing technical assistance and training.

Duties

• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• May supervise, coordinate, prioritize and lead the daily activities of a group of qualifiers/validators and schedule their workloads.
• Designs qualification/validation plans and protocols; researches and writes documents in support of project directives for the qualification/validation of instrumentation/computer systems. Performs and may oversee the development of qualification/validation activities for instrumentation and supporting software.
• Develops and oversees the creation of Standard Operating Procedures related to instrumentation including the administration of related supporting software.
• Maintains appropriate documentation of records, report sheets and laboratory logbooks as required by Standard Operating Procedures (SOPs).
• Provides scientific and technical leadership to junior staff members to ensure project deadlines and performance standards are met. Collaborates closely with Supervisor to set priorities and reach objectives.
• Surveys literature to remain current with developments in analytical instrumentation qualification and computer systems validation.
• Prepares and presents written reports on qualification/validation activities.
• Provides formal and informal training to laboratory personnel on instrumentation usage.
• Selects, justifies, and implements appropriate instrumentation, computer systems, and procedures to achieve product development support objectives.
• Ensure compliance with all Company policies and procedures, including safety rules and regulation.
• Performs related duties as assigned.

Qualifications and Knowledge

• Bachelor’s Degree in Science or related scientific filed from an accredited college or university, and nine (9) years related pharmaceutical laboratory experience, or an equivalent combination of education and experience.
• Responding to inquiries from management, employees and regulatory agencies.
• Working with a high degree of independence and of conceiving and achieving technical goals with little or no technical supervision.
• Training of junior staff.
• Leading the activities of technical personnel; making decisions and satisfying the needs of a qualification/validation program.
• Communicating clearly and concisely, both orally and in writing.
• Operating scientific and personal computers.
• Managing multiple projects, duties and assignments.
• Coordinating and reviewing the work of assigned department personnel.
• Technical Report Writing
• Establishing and maintaining cooperative working relationships with others.
• Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
• Pertinent SOPs related to analytical instrumentation qualification and computer system development life cycle.
• Data Integrity principals as they related to regulatory rules, regulation and guidelines.
• FDA, CGMP, and SOP regulatory rules, regulation and guidelines.
• Business, English usage, spelling, grammar and punctuation.
• Business, scientific and personal computer hardware and software applications.
• Supervision, leadership and training practices and methods.
• Current Company policies, practices and procedures, including safety rules and regulation.

Crest Solutions have an open position for a Validation Engineer to join our team.

In the Validation Engineer role, you will be required to support capital projects/equipment qualification, new product introductions and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of equipment, systems and processes. The following activities will be included as part of your role:

Responsibilities

       Designing, executing and reporting on validation studies for equipment, systems and processes.

       Ensuring validation studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.)

       Providing technical interpretation and guidance of current US FDA and EU validation requirements for solid dose manufacture, aseptic processing, lyophilisation, sterilisation and depyrogenation

       Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times

       Maintaining validation documentation through the validation lifecycle

       Participation in external regulatory inspections

Requirements & Qualifications

• Relevant Engineering or Science qualification. Previous validation experience in sterile manufacturing, solid dose and devices would be highly advantageous for the role. 
• 39 hour week with typical hours 8:00 to 16:30 (Mon-Thurs) and 8:00 to 15:30 (Fri) with occasional requirements to work outside these core hours and for business travel. The role reports to the Validation team leader.
• You will have the opportunity to work in an energetic friendly team where team-work is essential. Due to the diverse of the site and the validation work, you will get exposure to many areas of the business with the chance to grow your career and develop your technical and professional skills. 
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Why join Crest Solutions?

In Crest Solutions we understand that our people are our greatest asset. For this reason and many others, we take care of them. As part of the Crest Solutions team, you will be exposed to, and have the opportunity to work with, the latest cutting-edge technologies. The experience you gain in Crest Solutions will be multi-faceted.

This role also includes great personal benefits and professional growth opportunities. An example of what is offered to our team members is as follows:

        Competitive salary

        Full healthcare cover, leave benefits, life assurance, flexi-time and pension scheme

        A varied and exciting career with Crest Solutions with opportunities to work in a cutting-edge, innovative technological environment

        A structured approach to professional development opportunities with an educational assistance programme

Job Description

• Safe and efficient operation of site life systems, such as Fire Alarm, Gas Detection and Access Control.
• Effective contractor management.
• Continuous improvement initiatives to enhance the operations in Facility areas.

• Responsibility for the operation and maintenance of all site Facility systems on site, including but not limited to; Access Control, Fire Alarm System, Pest Control, Security, Site Communications, Sprinklers, Grounds & Building Fabric Maintenance, Plant Uniforms & General soft services.
• Ensure all regulatory compliance requirements are fulfilled.               
• Ensure correct spares are specified and maintained at adequate levels to maintain operations.
• Operate planned and unplanned maintenance systems as defined in Engineering Department procedures.  Implement procedures for new equipment as required.  
• Develop and implement maintenance strategies and plans for all equipment in Facilities.
• Manage Department performance against defined KPIs.
• Control and monitor safe working practices of team members and contractors while on site.
• Support the Technology Transfer initiatives for incoming new products. This requires good communication and close cooperation with key Technology Transfer personnel from other departments.
• Implement training programs and maintain up to date training records for key contractors such as Security personnel.       
• Instigate maintenance improvement projects to improve availability and efficiency.
• Lead quality investigations relating to Facility systems.
• Ensure compliance with the Quality Department Document Management System.
• Participate in the control of Safety and Environmental programmes.  Adhere to safe working practices as set out in the Safety Statement and other company safety rules.
• Participate fully in cross-functional training initiatives.
• Provide regular reports on the activities of the Facility & Utility group
• Assist with the formation and control of operational budgets.

• Leadership of site programmes to manage certain High Risk activities.
• Participate in site EHS activities and ensure that the Facility personnel comply with legislation and best practice.
• Actively foster an ethos and culture of safety awareness, where safety is accepted as an integral part of the overall business.
• Work with all GC personnel, contractors and visitors to ensure that all safety policies, procedures and regulations are fully adhered to across the site on an ongoing basis.
• Ensure compliance with legislative requirements as applicable to engineering/ maintenance systems.

• Ensure that team are well trained to safely and effectively carry out their roles. Develop training for relevant personnel with a particular focus on direct operational and technical support personnel.
• Preparation and delivery of training material as required.
• Ensure timely completion of all SOP training and assessment tasks.
• Ensure that all training and assessment is accurately and promptly recorded for themselves and other relevant personnel in accordance with TILGC procedures.
• Maintain and improve their professional knowledge base. Keep up to date with all current trends and relevant legislation.

• Participate fully in any cross functional training initiatives.
• Drive and promote the corporate values of Takeda-ism within the workplace.
• Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Beacon Events are completed in a timely manner after an event.

• Ensure timely completion of all SOP, reading, training and assessment.

• Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.

• 3rd level Engineering, or equivalent, required.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type