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.