Validation Lead

I am working with a well-established CDMO that has multiple sites across UK and that is now hiring for a brand new position in the form of a Validation Lead to support increasing demand on services.

Working specifically within the product manufacturing facility, the new hire will take full responsibility for equipment, cleaning and computer systems validation on this specific site. This will include responsibility for the site validation master plan, as well as responsibility in executing specific requirements.

Given the commercial nature of the facility, this role will not just have regular interaction with regulatory bodies but will also work closely with customers and therefore must have a strong appreciation of stakeholder management.

The future of the business is bright, with a vision to broaden services not just in commercial manufacturing but also within the clinical area. Over the past six months the company has taken strides towards strengthening future project pipeline and therefore this position has a great prospect.

Key experience:

· Strong pharmaceutical validation experience in a GMP setting

· Hands on experience in equipment and cleaning validations – CSV experience would be advantageous but knowledge of this area could also work

· Experienced in direct responsibility with key stakeholders and regulatory bodies

· Track record of validation master plan oversight and modifications

· Adaptable – this person will need to turn their hand to different challenges on a medium sized manufacturing unit

Keywords:

Validation, IQ, OQ, PQ, DQ, installation, commissioning, equipment, cleaning, engineer, specialist, lead, supervisor, csv, computer, systems, quality, assurance, manufacturing, GMP, protocol, master, plan