Lab Metrologist

Discover Veranova:

At Veranova we believe people are our most important asset and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising focus on quality compliance safety and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth and a desire to make a difference.

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility we develop solutions and processes that support and accelerate innovation.

Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.

Role Overview:

The Lab Metrologist is responsible for the timely installation maintenance repair calibration and qualification for instruments balances and other equipment used by the Quality groups within the Quality Control laboratories Analytical R and D groups and the IPC laboratory at the Edinburgh site. The incumbent ensures that Standard Operation Procedures are technically sound and provide regulatory compliance for all.

Core Responsibilities:

Role specific Accountabilities

• Schedules executes and supports instrument PQ calibrations and preventative maintenance both internal and externally contracted activities in such a way so as not disrupt the analysts using the instruments. Responsible assuring instrument maintenance and usage logbooks have been maintained.
• Negotiates and manage contracts with external vendors and contracted services as required. Oversee the work of contracted personnel to install/modify equipment and systems in accordance with the specific needs of the QC and QS groups while meeting all cGMP and EP/USP requirements.
• Peer review of metrology documentation and Labware LIMS records.
• Directly involved with and supports investigations that are instrument related.
• Perform trending analysis on Lab Investigations Deviations Out of Specifications
• Support the process to evaluate purchase and install new instrumentation. Interacts with internal and external vendors to ensure the proper instrumentation is identified to support the needs of the business. Evaluates and recommends appropriate application of new software packages as well as upgrades of software/firmware/hardware.
• Provide support for all laboratory instruments to QC and QS analysts.
• Liaise with the validation and QC teams and work as part of the team and be able to work independently.

IT Accountabilities

• Once experienced has been gained in use of the systems to act as Administrator or Deputy Administrator for laboratory software.
• Support Electronic Record and Electronic Signature assessment for laboratory computer systems.
• Provide assistance to IT in relation to laboratory instrument PCs.

Qualification Accountabilities

• Assist in the management of equipment qualification activities (DQ/IQ/OQ/PQ preparation) for all new laboratory instruments.
• Prepare and execute Qualification document packages including but not limited to VMP OQ PQ and EQRs.
• Operating documented systems to ensure that duties are performed to GMP standards.

Other Accountabilities

• Performance of duties in a safe and efficient manner according to the written procedures of the company pharmacopoeia and regulatory requirements.
• Write and/ or assist in writing instrument related SOPs
• Conducts all work in compliance with EP/USP and cGMP standards and all other appropriate MHRA US FDA and local regulations.
• Training other analysts on new instruments.
• All other duties as reasonable required.

Qualifications:

• Operation of HPLC and GCF familiarity with EP/USP and cGMP regulations.
• Ability to exercise independent judgment in the application of scientific principles pertaining to analyses as related to this business and operation.
• Proficiency with computers and other software packages relevant to instillation modification calibration and qualification of instrumentation systems and equipment.
• Strong communication skills; written and verbal.
• Possess strong organisational skills.

Preferred

• Bachelors Degree in science related subject.
• Experience in a cGMP environment.
• Experience or familiarity with Labware LIMS and the Instrument Manager module.
• Experience or familiarity with Master Control and Trackwise.
• Recent relevant experience in bulk pharmaceutical/API manufacturing or specialty chemicals.
• Experience or familiarity of Project management
• Experience or familiarity with an ERP system such as Avantis management system

Our Commitment:

• Inclusive Culture: At Veranova an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.
• Financial Wellness: The company provides an industry-leading compensation package and this position is eligible for an annual performance bonus in accordance with the terms of the applicable bonus plan. You will also receive excellent pension contributions with the option of making contributions via salary sacrifice and access to discounts from major online and high street stores.
• Health & Wellbeing: As well as being entitled to 25 days annual leave plus recognised Scottish public holidays our colleagues are also eligible to participate in benefits such as our Health Shield Cash Plan Cycle2Work Scheme life insurance income protection and GP Anytime.
• Professional Development: Opportunities for continuous growth and development through resources such as LinkedIn Learning functional career pathways and individual Personal Development Plans to map out your future with us.

Additional Information:

Under UK legislation we are required to ensure that all employees have the legal right to work in the UK both at the time of offer and throughout their employment. Please note that we are not able to provide sponsorship for this role so applicants must have the necessary right to work in place independently.

Agency and Search Firm Representatives: Veranova will not accept unsolicited applications/CVs from agencies and/or search firms for this job posting.

Veranova 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.

All applications are carefully considered and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.