2nd Line Engineer
Role details
Job location
Tech stack
Job description
To perform routine and non-routine analysis using traditional and modern analytical techniques, as required by the Lead Scientist or customer representative.
To review analytical data for GMP compliance.
To prepare and approve results for tests in which they have received the appropriate training and are deemed competent.
To train as required, other Eurofins or client employees in analytical techniques and electronic system in which the Analyst is competent. Potential to be involved in super user groups.
Must be able to coach and mentor junior members of the team.
Development and validation of analytical procedures used for API's, drug products and regulatory starting materials with minimal supervision from senior/colleagues.
To initiate and follow-up OOS results and action limits as per customer procedures.
To identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement.
To document data as dictated by current AZ policies and procedures.
To ensure that all documentation is carried out on time, is accurate and legible and conforms to the relevant quality standards.
To update any relevant documentation including SOPs when requested by Lead Scientist or client representative.
To participate in the preparation / authoring of protocols and reports.
Ownership of packages of work (e.g. Technical, Change Control and deviation investigation) with agreement from client.
Attend regular client/Eurofins team meetings. Actively contributes to concepts sharing learning and understanding to the wider Analytical community.
Interfacing cross functionally including external clients and third party vendors.
Ensure that the customer gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards and GMP compliance.
To understand customer's requirements and strive to meet or exceed those requirements keeping in mind the customer process end points.
To deal with customer queries and contact designated personnel, with appropriate support from onsite leadership, with any relevant information or issues relating to test results or the service in general.
To become fully familiar with and keep up to date with any technological or method revisions in their area, ensuring their training is complete and adjusting their work as required with approval from the Lead Scientist.
To collect and measure productivity through agreed metrics such as number of tests performed, cycle times, lab/product issues, number of hours worked per project, etc.
To keep the laboratory area clean and tidy in both 'seen' and 'unseen' areas.
To adhere to all customer standards in the areas of safety, housekeeping and quality, notifying management of any discrepancies.
To have a clear understanding of the customer relationship and service goals.
Assist the Lead Scientist as required in terms of team planning, resourcing and recruitment as needed.
To ensure that all decisions are handled with customer service in mind.
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Requirements
A degree in Chemistry or a related discipline is essential.
Extensive analytical experience in the pharmaceutical industry with many years hands on laboratory experience working primarily in the development of drug products or other closely related areas.
Expertise in analytical development, validation and troubleshooting across small and/or large molecules (peptides/oligonucleotides) using traditional analytical techniques as well as modern instrumental equipment (HPLC/UPLC, Karl Fischer, Dissolution, Mass Spectroscopy and other Spectroscopic techniques). Either small or large molecules sufficient, both is advantageous.
Highly adept in interpretation and scientific review of analytical data and documentation demonstrating a keen eye for detail, readily identifying and addressing anomalies.
Able to support junior members of the team passing on knowledge/experience as well as best practices from own experiences and learnings.
Track record simultaneously leading large packages of work and projects, effectively co-ordinating cross functionally between teams and scientists to deliver project goals.
Capable in the co-ordination and management of external outsourcing partners such as CROs and external manufacturing sites.
Thorough understanding of requirements for working in a GMP environment.
Proactive and adaptable with a strong focus on continuous improvement and drive for self-development.
Highly solution focused, using own initiative to effectively problem solve, working collaboratively with others across a wide network of scientists.
Strong written and verbal communication skills to effectively interact with stakeholders and colleagues
Confident in the use of typical IT software such as MS office and excel as well as experienced in the use of common Chromatography data systems such as Empower and others.
Highly values collaboration and relationship building working well with others to achieve key project deliverables and contributing to a positive work environment.
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Benefits & conditions
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