Lab Metrologist

About the job

An exciting opportunity has arisen for a Lab Metrologist to join our team on a permanent basis in our Validation Department.

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 Health site. The Lab Metrologist ensures that Standard Operation Procedures are technically sound and provide regulatory compliance for all. 

The Company

We are a global leader in the development and manufacturing of active pharmaceutical ingredients, with expertise in highly regulated and complex chemistries. We have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle.

Key responsibilities

• 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. 
• Conducts peer review of metrology documentation and Labware LIMS records.
• Directly involved with and supports investigations that are instrument related. 
• Performs trending analysis on Lab Investigations, Deviations, Out of Specifications
• Supports 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.
• Provides support for all laboratory instruments to QC and QS analysts.
• Liaises with the validation and QC teams and work as part of the team and be able to work independently.   
• Once experienced has been gained in use of the systems to act as Administrator or Deputy Administrator for laboratory software. 
• Supports Electronic Record and Electronic Signature assessment for laboratory computer systems. 
• Provides assistance to IT in relation to laboratory instrument PC.
• Assists in the management of equipment qualification activities (DQ/IQ/OQ/PQ preparation) for all new laboratory instruments.
• Prepares and executes Qualification document packages including but not limited to VMP, OQ, PQ and EQRs. 
• Operates documented systems to ensure that duties are performed to GMP standards.
• Responsible for contributing to audit readiness and for participating in quality audits with MHRA, FDA, other Regulatory Agencies and customers, as needed.
• Ensures work is in compliance with all state and federal regulations, including but not limited to GMP, MHRA, DEA, FDA, etc.

What you need for the role

To succeed in this role you will have;

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

How will you be rewarded 

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, life insurance and receive 25 days annual leave plus public holidays.  Employees will also be eligible to participate in a health cash plan, savings plan, Cycle2Work scheme, technology savings and enhanced family friendly polices to help support our people during important, life changing moments.

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. 

If you have the necessary skills and experience to join our team, please apply online. For any queries or should you require any reasonable adjustments to support your application please let your recruiter know when they contact you.
 
 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. 
 
 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.