Description
Facilities & Utilities Validation Lead required to join a global pharmaceutical company in Wiltshire.
The Validation Engineer will be required for a 12 month contract to be responsible for the generation, execution and review of all life cycle validation documentation for the qualification of facilities, and utilities.
Roles and Responsibilities
. To ensure that all documentation is prepared, authorised and completed in a timely manner.
. To supervise work of those undertaking validation activities
. To ensure that all tasks are carried out in an effective and efficient manner.
. To liaise with the various departments involved in the qualification and validation work to ensure the efficient performance of the related tasks.
. To maintain an understanding of current international regulatory, ISO, corporate and client requirements relevant to the section. To ensure compliance with the sections and site procedures.
. To communicate effectively with others on site and the client associated with the project.
. To assist in the investigation of problems and provide support to the business in resolving quality issues
. To ensure that adequate training has been received and documented
. Comply with GMP requirements and company rules, policies and procedures.
Skills within the following areas:
. Clean room commissioning
. HVAC
. Water for Injection generation, storage & distribution
. Clean steam generation & distribution
. Purified Water generation, storage & distribution
. Compressed gases generation, storage & distribution
. Building Management Systems
. Restricted Access Barrier Systems
Qualifications/Experience:
. Significant demonstrable experience of facilities and utilities qualification
. Higher level qualification preferable
. In-depth knowledge and understanding of cGMP.
. Self-motivated, with a pro-active approach to taking on challenging assignments.
. Previous experience of applying V model approach to validation activities
. Creativity, judgement and analytical thinking.
. Ability to work with critical timelines.
. An excellent planner, who can envision short-term milestones to succeed in the long-term.
If this is you please apply today.