Are you a highly qualified professional? 

Could complement the Zener Engineering Services team?

Do you have significant GxP experience? (10+ years)

We have a vacancy for a Senior Consultant.

Please contact ZES with your c.v. 

Initial 6 Month Contract - Remote Working - Outside Of IR35 - Infrequent Travel Expenses Paid.

Immediate start. Rate dependent on exeprience.

Are you a highly qualified software coder? 

ZES need an experienced Software Developer / Tester to support a project with automated and manual software testing. 

The project is a medical diagnostics android based medical device product.

Experience Required:

• 5 years’ experience working as an Automation Test Engineer or Software Test Engineer in an Agile Development environment.

• Experience with creating new tests in automation testing tools & frameworks, such as:

 - TestNG

 - Appium

 - Pytest 

• Essential that you are currently or have previously worked in the Medical Diagnostics Industry working with a Point-of-Care or RDT diagnostics manufacturers.

• Essential that you have a proficient working knowledge of python and Java code languages.

• Experience with the Jenkins CI/CD system.

• Experience working with AWS products for at least 1 year.

• Experience with FDA design control requirements (21 CFR 820.30) as applied to medical device software and medical device regulations including ISO 13485, ISO 14971, UL 2900 Cybersecurity, IEC 62366, and IEC 62304

• Experience with quality and information security management standards (e.g. ISO 9000, ISO 27001)

• Experience of development projects, testing and operation of devices that utilise cellular communications, for the reporting of diagnostic test and device data to country healthcare programs and diagnostics manufacturers for a range of Point-of-Care and RDT devices.

Please contact ZES with your c.v. 

Due to the number of enquiries ZES have recently received, we are looking for CSV Consultants with the following experience:

• Expertise in the understanding and efficient application of GAMP, US FDA and EU Medical Device regulations, and Data Integrity concepts
• Excellent knowledge of GMP, GCP, GDP, GLP etc
• Willingness to stand up for GxP Quality
• Ability to work collaboratively with cross functional multi discipline teams across international boundaries and time zones
• Well developed communication skills when interacting within department, and internal and external customers
• Ability to self manage during times of high workload and tight deadlines
• Spreadsheet Validation
• DocuSign Validation
• MD Software Validation
• Familiar with Project Management concepts within a recognised framework (such as Prince 2 and Agile)
• 10+ year’s Medical Device industry experience
• 10+ year's experience in CSV, with hands-on experience
• Relevant degree or significant experience in the field
• Significant Blue Chip MD Experience
• Project Management experience

Remote working available depending on project requirements.

Please contact ZES with your c.v. using the form below.

ZES look forward to hearing from you.

Due to the number of enquiries ZES have recently received, we are looking for CSV Consultants with the following experience:

• Maintain all documentation pertaining to Computer Systems Validation.
• Authoring, review, approval and execution of validation protocols, reports, procedures, policies, and masterplans etc.
• Identify current and future computerized systems validation needs through in-house / external assessments.
• Planning and performing routine and project validation work related to computer, computerized equipment (automated systems) installed onsite and cloud-based systems to meet current GMP regulations and guidelines, industry best practice and company policy.
• Work with systems owners to ensure validation is conducted prior to deployment of GxP systems and systems are maintained in a validated state.
• Act as a Single Point Of Contact (SPOC) / Subject Matter Expert (SME) for all CSV related queries and issues.
• Ensure all CSV related control elements are safe, effective, and qualified in compliance with industry standards and regulatory expectations.
• Support / lead the processing and managing of associated quality records including assessments, audits, deviations, CAPA’s, investigations.
• Support all hardware and software updates and revisions.
• Ensure that new process systems are included in the plant maintenance and calibration program.
• Participate on project teams through all phases of projects - conceptual and detailed design,  equipment procurement, construction, installation, start up, commissioning and qualification, and system release.
• Project management of process system upgrades and modifications
• Demonstrable understanding of Computer Systems Validation (CSV) and Data Integrity (DI) requirements for regulated industries and its development life cycle approach.
• Ideally some tangible exposure to cGMP regulations related to CSV including CFR 21 Part 11, GAMP 5® and Data Integrity.
• A minimum of 10 years’ experience working within Pharma/Medical/Biotech or similar GMP environment as part of an engineering, technical services, or automation / IT function.
• Knowledge of networking and information transfer systems, such as, SCADA and Enterprise systems.
• Validation experience within automated systems is preferred.
• A good understanding of general manufacturing activities and automated assembly.

Remote working available depending on project requirements.

Please contact ZES with your c.v. using the form below.

ZES look forward to hearing from you.

Due to the number of enquiries ZES have recently received, we are looking for CSV Consultants with GxP Cloud experience. Key experience requirements include:

• Expertise in the understanding and efficient application of GAMP, US FDA and EU Pharmaceutical regulations, and Data Integrity concepts
• Excellent knowledge of GMP, GCP, GDP etc
• Willingness to stand up for GxP Quality
• Ability to work collaboratively with cross functional multi discipline teams across international boundaries and time zones
• Well developed communication skills when interacting within department, and internal and external customers
• Ability to self manage during times of high workload and tight deadlines
• ERP Validation Experience (SAP)
• CRM (Salesforce)
• Vault Medical Communications
• Electronic Documentation Management Validation (EDM)
• Familiar with Project Management concepts within a recognised framework (such as Prince 2 and Agile)
• 10+ year’s pharmaceutical industry experience
• 10+ year's experience in CSV, with hands-on experience
• Relevant degree or significant experience in the field
• GxP Cloud Experience
• Significant Blue Chip Pharma Experience
• Project Management experience

Various contract lengths, outside IR35. Good rates plus expenses available.

Remote working available depending on project requirements.

Please contact ZES with your c.v. using the form below.

We look forward to hearing from you.

ZES currently have a requirement for a SIP Thermal Mapping Validation Consultant \ Engineer to requalifiy the following :

• Formulation vessels. 
• Transit vessels. 
• Sterile filter assemblies.
• Cold Store (2-8°C).  

3-4 month contract, outside IR35.

Please contact ZES with your c.v. 

The role is focused on the development, monitoring and advising on the performance of the quality management system, producing data and reporting on performance, measuring against set standards. The goal is to help the project  by ensuring that products and services consistently meet quality requirements. The main focus of the project role is:

• To maintain and improve the document management system and facilitate the efficient running of the Quality Management System (QMS).
• To assist in the review of manufactured APIs ensuring all batch documentation meets GMP standards, finished product specifications are met and GMP compliance is adhered to in line with internal procedures and GMP regulations.
• To lead and contribute to the execution of the day to day operational activities of the QA department and to manage the Quality Assurance Manager and Quality Assurance Officer for the Project.

Core Competencies

• 15+ Years Experience in a Quality Management Role:
• GMP experience
• Pharmaceutical experience
• Specials experience 
• APIs experience
• Evidence based decision making and problem solving skills

Contact ZES for a full project role description.