Job Description

Company Overview

NextPharma is a leading European contract manufacturer in the pharmaceutical, biotech, and healthcare industries. With a workforce of approximately 2,300 colleagues across Germany, France, the UK, Norway, and Finland, we pride ourselves on delivering fast, flexible, and tailored solutions to meet global market demands.

Job Purpose:

This role reports to the QC department managers and will primarily perform maintenance, calibration and qualification of analytical instruments and metrology equipment to ensure accuracy, reliability, and compliance with regulatory standards in accordance with agreed timelines. The ideal candidate will therefore have a pharmaceutical background and have ideally gained experience maintaining laboratory equipment within a cGMP, FDA and MHRA regulated environment.

Key responsibilities and accountabilities:

Collaborate with cross-functional teams to support analytical method development and validation Perform routine maintenance, calibration, and qualification of analytical instruments such as HPLC, GC, UV-Vis, FTIR, and balances with a strong understanding of metrology principles and practices Troubleshoot and resolve issues related to instrumentation and metrology equipment. Write (where applicable) and execute qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Provide technical expertise and training to laboratory personnel on the proper use and maintenance of analytical instruments
Maintain accurate records of all maintenance, calibration, and qualification activities and work to defined equipment maintenance and qualification schedule

Primary contact for third party vendors who support equipment qualification, maintenance and repair including maintenance of service contract

Comply with company health and safety procedures

Person Profile:

Technical Support Scientist/Specialist

Personality:

Results oriented with a positive outlook and clear focus on high quality output. Attention to detail, Precision in performing maintenance and calibration tasks with accurate record-keeping and documentation skills.

Solid planning and organizational ability with the a ability to prioritize tasks and manage time effectively; Reliable, tolerant, and dependable: Comfortable dealing with senior managers and customers: Enjoy working in a fast, stimulating environment. Goal-oriented: Able to work under pressure and meet deadlines; Excellent communication/ presentation skills. Able to get on with others and be a team player but equally comfortable working independently.

Personal Situation

Flexible and able to work extended hours when required.

Specific Job Skills:

Required:

Relevant qualification, HNC/HND/Science Degree or Equivalent

An understanding of drug development and manufacturing processes

3+ years of experience in maintaining and qualifying analytical instruments

Strong understanding of metrology principles and analytical instrumentation technologies

Skilled in analytical techniques e.g., HPLC, Dissolution, Gas Chromatography, and wet chemistry techniques

Excellent problem-solving skills and attention to detail

Able to communicate well with others, both laboratory and non-laboratory based

Able to work with minimal supervision.

Good understanding of quality control, SOP and GMP adherence

Able to communicate well with others, both laboratory and non-laboratory based

Able to work with minimal supervision.

Familiarity with regulatory requirements and industry standards (e.g., FDA regulations, GMP guidelines)

Desired:

Have a broad knowledge with and experience of working within a cGMP/GLP environment.

Experience of working within a pharmaceutical or biotechnology industry

Ability to work to key regulatory and compliance requirements

Experience of chromatographic data package Chromeleon, UV vison security, FTIR Lab Solutions and Karl Fisher Tiamo software

Experience of data reporting and checking data within a GMP environment

Understand and demonstrate a pragmatic approach to problem solving with GMP constraints.

Computer skills:

Must be competent in the use of MS Office, particularly Excel and Word,
e-mail and internet. Previous use of chromatographic acquisition software is desired but not essential.

Literacy and Numeracy:

Must be competent in writing reports both for internal use and for customers. Must be competent in the interpretation of analytical data.

Business Presentation Skills

: Must be an excellent face-to-face and telephone communicator.

Management Skills

: Must be skilled in leading/ training/guiding/mentoring others

Please note: Only candidates with permanent Right to Work in the UK will be considered.

NextPharma is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.

Job Types: Full-time, Permanent

Benefits:

Company events Company pension Cycle to work scheme Free parking Health & wellbeing programme Life insurance On-site parking Referral programme Sick pay
Ability to commute/relocate:

Livingston EH53 0TH: reliably commute or plan to relocate before starting work (required)
Work authorisation:

United Kingdom (required)
Work Location: In person