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Senior Technical Specialist

2 weeks ago

Deeside, Flintshire, United Kingdom SRG Full time £40,000 - £60,000 per year
  • Job Title: Senior Technical Specialist
  • Contract: 12 months
  • Location: Deeside
  • Pay: approx. 45-50k
    (DOE)

SRG are partnered with a global medical products and technologies company. Our client is focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care.

We are seeking a
Senior Technical Specialist
to join their Deeside team.

Position Overview:

The Senior Technical Specialist within the Physical Testing department is responsible for providing technical input for all operations with the laboratory, ensuring accurate and efficient testing of raw materials and product to meet regulatory requirements. Note: This role will work with products from all of business units.

The role requires working closely with the Team Leads in the department, developing and validating new novel test methods and implementing standard methodologies.

This role is crucial in designing and implementing test protocols, maintaining laboratory equipment end ensuring compliance with quality standards.

Key Responsibilities:

  • To act as a technical expert on behalf of the T&I organization by providing advice, guidance and expertise in Physical Testing and Material Science.
  • Within a design control framework, lead scientific projects and provide full physical testing support, including test method development/validation, design verification/validation testing.
  • Provide technical support and guidance to manufacturing sites; support research and trouble-shooting activities, define and execute strategies for method validations and transfer of methods when required.
  • Lead equipment qualification and calibration activities in accordance with company procedures, including software validation activities for the deployment of equipment software packages within the Physical Testing Laboratory.
  • Further develop the technical expertise of the department through research, training, procurement of equipment and software, and managing relationship with vendors, industrial and academic contacts.
  • Update, review, approve technical data, test results, protocols, reports, compliance records and general laboratory documentation.
  • Collaborate with relevant project and departmental managers to effectively co-ordinate workloads, timelines and priorities within the department.
  • To keep abreast of current literature to continuously develop physical testing methods using best practice to investigate new technologies and business opportunities.
  • Maintain an awareness of the status of core technical challenges and opportunities in areas of expertise for physical testing.
  • Identify and lead investigations for NC/OOS/Deviations/Change controls in relation to physical testing procedures and processes; ensure prompt resolution of identified problems and provide appropriate recommendations for remedial/corrective actions.
  • Collaborate with team members to plan, direct and implement continuous improvements in lab systems and processes.
  • Provide technical oversight and resolution of any physical testing NPD/ Life cycle management technical issues.
  • Deliver in-direct scientific or technical mentorship and leadership to analysts to enable them to meet their project objectives, including training in physical test methods.
  • Work collaboratively to build technical communities across different functional groups.
  • Support lab analysts in daily laboratory operations and interface with functional groups on scientific issues, study design and project technical requirements.
  • Establish and maintain effective communication channels to provide accurate information and communicate issues, gaps and constraints to management and wider teams.
  • Ensure highest levels of safety in accordance with EHS policies by creating and maintaining Risk Assessments and COSHH assessments.

Qualifications/Education:

  • Bachelor's degree or equivalent in Science/ Technical/ Engineering and approx. 7+ years of Med Device/ Pharmaceutical Laboratory work experience with increasing responsibilities.
  • Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (IS013485:2016 and FDA 21 CFR Part 820) and GMP Guidelines and Regulation.
  • Strong background in Physical Testing
    ; significant experience, track record and knowledge within a physical testing environment or
    Material Science background
  • Possess a flair for problem solving, identifying inefficiencies and implementing solutions.
  • Microsoft Office skills are essential.

Skills & Experience:

  • Strong experience working in Medical Device/Pharmaceutical Industry within an R&D/product development role.
  • Ensures use of good scientific practice and the development and validation of appropriate methods for testing.
  • Designs and constructs a series of analysis to understand complex technical issues and to evaluate new technologies and business opportunities.
  • Competent to provide technical support and advice to other functions and franchises; serves on various teams as a functional leader.
  • Provides advice and oversee the implementation of technical solutions.
  • Competent in following, adhering to, writing, and the review/approval of technical reports, validation protocol/reports, SOP's, OCI's, TD fs, laboratory investigations etc.
  • Demonstrates a high level of creativity and independence in areas of assigned responsibility and has good command of the relevant scientific and technical literature.
  • A good team player, proactive and recognizes opportunities for improvement; understands impact of issues noted in one study to the overall project; shares experiences and best practices,
  • Competent to train new and inexperienced members of staff in test method procedures, use, calibration and maintenance of laboratory equipment to support their continued development.
  • Understanding of product development process and design controls.
  • Provides guidance and recommends areas for improvement and training.
  • Competent in writing Risk Assessments, Safe Systems of Work and COSHH assessments.
  • Excellent, written and oral communication skills are required,
  • Must be effective working individually and as part of multi-disciplinary teams.