Specialist, Equipment Management in Cwmbran

Nanopharm, an Aptar Pharma Company, is a world leading specialist contract research and development organization offering product development services for orally inhaled and nasal drug products (OINDPs). Nanopharm operates a fee-for-service model, helping its clients navigate the scientific, technical and regulatory challenges in developing nasal and respiratory drug products from discovery through to clinical investigations (‘IND’).

Its service offerings provide the most efficient path to success for its clients by providing an integrated product development service covering:

• Advanced materials characterization
• Analytical method development
• Formulation development and testing
• Inhaled biopharmaceutics

These early phase services aid successful product development by understanding how material properties and processing conditions influence product functionality and therefore reduce risks and expedite drug development timelines. Nanopharm’s proprietary technology and analytical platforms for advanced materials characterization, formulation & device development and in-silico modelling of in vivo behaviour, have provided Nanopharm a technical competitive edge, helping it become an international market leader.

You should work here because we:

• Attract and develop high performing people.
• Promote a diverse and inclusive work environment.
• Allow for failure by allowing people to make mistakes through an open and trusting environment.
• Invest in the development of employees through local, regional and global career opportunities.
• Contribute to the communities where we reside.

Nanopharm is a prominent player in the Inhalation industry, with our laboratory service provision in Wales, United Kingdom. We specialise in the development and testing of inhalable and nasal pharmaceutical products, collaborating closely with pharmaceutical companies to ensure product safety, efficacy, and regulatory compliance.

This position is an integral member of the Operations team and will be responsible for providing professional and effective equipment maintenance and management activities.

Job Details / Responsibilities

Job descriptions cover approximately 85% of a role and are not an exhaustive list of responsibilities and duties. You are expected to carry out other activities that are within reasonable scope of the role.

Role Overview

This position is primarily responsible for:

• Planning and coordinating qualification and calibration activities with vendors for laboratory equipment.
• Review and approve vendor qualification plans, data, and reports for accuracy, good documentation practices (GDP), and completeness.
• Work with Management and Quality to develop instrument qualification lifecycle documents including change controls, user requirement specifications (URS), risk assessments, IQ/OQ/PQ documentation, and 21 CFR Part 11 compliance (software).
• Drafting and updating procedures related to equipment use and lifecycle.
• Supporting investigations caused by non-confirming instruments/results and implement solutions (CAPA).
• Communicate with vendors for instrument troubleshooting and issue resolution.
• Maintain accurate documentation of all activities with lab equipment.
• Reviewer of environmental monitoring system and respond to alarms/alerts as described in procedures.
• Manage on site vendors in the laboratory by making sure they are accompanied.
• Aid in instrument software validation and risk assessment creation.
• May be asked to partake in audits including customer, regulatory, and accreditation.
• Manage in house instrument preventative maintenance tasks and periodic calibration checks on ancillary equipment.
• Identifying root causes for equipment breakdowns and working with subject matter experts to implement appropriate corrective and preventive actions.
• Develop the internal technical capabilities of Nanopharm personnel and where feasible and appropriate, broaden the internal planned maintenance program for Nanopharm equipment to reduce outsourcing requirements.
• Actively take part in continuous improvement activities as needed to drive forward business improvements.
• Supporting Gemba Walk throughs to ensure active participation between Operations and Pharmaceutical Development team members.
• To lead and manage a team of Laboratory Technicians.
• Oversee the organisation and replenishing of materials needed for conducting routine planned equipment preventative maintenance.
• Ensure all relevant staff are informed and aware of planned/unplanned maintenance qualification and repairs.
• Deploying and maintaining systems and processes to ensure continued supply chain.
• Accountable for the generation of all purchase requisitions related to equipment.
• Organising and conducting daily checks and verifications on critical equipment’s functionality (balances, humidity chambers, fridges/freezers, etc.).
• Organising calibration, preventative/reactive maintenance on equipment.
• Lead the implementation of new equipment with the close support of subject matter experts and management, including:
• Evaluating options to present to stakeholders/Site Leadership Team (including the repurposing of existing equipment workstations).
• Sourcing and procurement including CAPEX request justification.
• Change control initiation.
• Installation and associated qualifications (if required).
• Responsible for the routine maintenance/calibration schedule.
• Establishment and management of a secure supply chain of critical spare parts for equipment to minimise downtime in case of breakage.
• Support the acquisition of critical operational effectiveness data and Key Performance Indicators (KPIs) for the Operations function as required.
• Use these KPIs to determine appropriate remedial actions (e.g. training programmes or improved maintenance plans).
• Conducting data trending analysis to pre-emptively identify performance issues or non-compliance with SOPs, with equipment or facility services.

Basics

• Always promote Nanopharm & Aptar’s best interests by the positive and effective way you perform your duties modelling our Core Values and Rules of Leadership.
• Always comply and proactively engage with Environment, Health, Safety and Sustainability policies, procedures and instructions to ensure the safety of you and your colleagues.
• Always comply and proactively engage with Quality policies, procedures and instructions to ensure we deliver quality work, data and reports.
• Read and understand all assigned Standard Operating Procedures (SOPs) via the Quality Management System (QMS) in the timeframe specified.
• Maintain an up-to-date training record and submit to your line manager at least annually for review, making updates and amendments as necessary.
• Complete timesheets, expenses claims, objectives and appraisals in a timely manner as specified by Stakeholders and in line with the relevant company policies.
• Ensure confidential information pertaining to the company is not divulged to 3rd parties without the appropriate permission.
• Ensure use of IT equipment (e.g. phones, laptops, etc.) is in line with the appropriate Aptar policies.

EDUCATION, Experience & RELEVANT Skills

Education & Qualification

• A first degree in a science, pharmacy or relevant disciple could be advantageous but not essential.

Experience

• Previous experience of working in a lab-based environment.
• Prior experience working in a regulated/GMP environment preferred.
• Familiarity with regulatory compliance standards in laboratory settings.
• Experience with laboratory instrumentation software validation (advantageous but not essential).

Skills

• Awareness of regulatory requirements e.g., Control of Substances Hazardous to Health (COSHH), Good Laboratory Practice (GLP).
• Vast laboratory equipment knowledge.
• Procedural skills for the use of various laboratory instrumentation.
• Basic word processing and Excel spreadsheet skills.
• Good written and oral communication skills.
• Team-oriented work ethic.
• Confident working in a team and using own initiative.
• Detail-oriented and highly organized.
• Proven flexibility in adjusting to a rapidly evolving workload and staying calm under pressure.
• Critical thinking and problem-solving skills.
• Always displays adherence to and promotion of the company values.
• Takes ownership for own personal development.

What we offer:

• An exciting, diverse and value based working environment.
• Award-winning corporate university offering personal development and training opportunities.
• Competitive base salary and performance-based bonus plan.
• Innovative benefits plan, which includes: medical, life, disability and wellness.

Be You. Be Aptar

Aptar is an equal opportunities employer. We believe that a diverse workforce is key to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief.

Location Statement

For additional information about location requirements, please discuss with the recruiter following submission of your application.