Position Overview & Specifications
JOB DESCRIPTION: Junior SDM Validation Engineer (P01)
As a Validation Engineer, in the Drug Product Manufacturing Group, you will be accountable for validating/qualifying the systems, equipment and utilities used in the development and clinical manufacture of a range of solid dosage forms.
An individual contributor role reporting to the SDM Validation and Technical Support Lead, applying technical, control system and engineering knowledge to the design and validation of new equipment, systems, utilities and cleaning operations within the solid dose manufacturing area in Sandwich. The role will also include some safety and management of the full asset lifecycle. You will have the opportunity to liaise with Key stakeholders in DPS, DPD, PGS, GWS, GA, Quality, Safety and external subject matter experts
You will help to design robust manufacturing solutions and cleaning operations to demonstrate systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.
Colleague will work closely with operational and technical teams within department to validate equipment, utilities, cleaning operations and systems. Colleague will be expected to interact with Global Workplace Solutions, Quality Assurance and Environmental Health and Safety to bolster the manufacture of solid oral dosage forms for clinical supply.
Working in the Drug Product Manufacturing Group, Drug Product Supply, Pharmaceutical Sciences Small Molecule (PSSM), the incumbent reports to the SDM Validation and Technical Support Lead. This role liaises with key stakeholders in DPS, DPD, PGS, GWS, Quality, Safety, and external subject matter experts. The role typically operates as an individual contributor at a local level contributing to department and cross group activities and input to cross department initiatives. This engineer will be a recognised SME in certain aspects of either equipment, facility, or system validation.
Requirements:
- Ideally educated to degree level in Chemical, bio-medical, bio-engineering, mechanical engineering or equivalent however candidates with a formal engineering qualification i.e. BTEC Level 4, HND / HNC or equivalent with intermediate experience in the pharmaceutical industry will also be considered.
- Working knowledge of equipment, facility and utility asset lifecycle management from initial design and procurement through to validation and operational use.
- Awareness of cleaning validation activities utilising a matrix approach.
- Awareness of GAMP 5 regulations.
- Awareness of computerized systems validation and CFR21 Pt 11
- Comprehension of facility design and associated building management systems.
- Suitable comprehension of engineering operations including instruments, controls and mechanical aspects of manufacturing equipment and associated services.
- A working knowledge of GMP and demonstrated comprehension of compliance and quality management including change control and data integrity.
- Experience of Safe Systems of Work and risk assessment tools used in both Quality & Safety areas beneficial.
- Evidence of planning and organizational skills in the project management of operational aspects of capital projects.
- Good stakeholder management, organisational and communication skills (both oral and written) and demonstrated skills in team matrix working.
- Proven ability to deliver technical reports and presentations.
- Knowledge of solid dose manufacturing techniques is desirable.
- Schedule and execute validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines.
- Coordinate and convey all testing with affected functional groups and evaluates test results.
- Execute validation activities to include Change Control initiation, protocol preparation, scheduling, Factory Acceptance Testing, protocol execution, data review and final report generation.
- Assist with generation of cleaning validation documentation to aid validation and verification studies.
- Accountable for completion of fully system lifecycle activities associated with equipment, utilities or facilities from project initiation through maintenance of the validated state to retirement / redesignation.
- Participate in development / improvements to the validation program as needed to remain current with cGMPs and industry standards.
- Participate on teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
- Participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
- Participate and present data in Regulatory Agency, Customer, Corporate and Internal audits when necessary.
- Assist additional focus areas: Automation, Facility Support, Process Development, Capital Projects
- Assist in ensuring future equipment meet the technical requirements of the operation.
- Contribute to the selection and integration of new equipment and services, ensuring validation, quality requirements and the process capability of the equipment is in line with pre-defined needs.
- Support and develop equipment/services robustness and manage the risks and impact of failure.
- Manage minor projects which include all operational and financial aspects. Drive quality, safety and continuous improvement related activities.
- Deliver training and assistance to ensure efficient use and deployment of equipment.
- Provide immediate troubleshooting and manufacturing support during manufacturing operations.