Validation Specialist/ Pharmaceutical

Job Title: Validation Specialist/ Pharmaceutical
Contract Type: Permanent
Location: Bolton, Greater Manchester
Salary: £35000 - £40000 per annum
Reference: J910842_1636110144
Contact Name: Tom Hammond
Contact Email:
Job Published: November 05, 2021 11:02

Job Description

Validation Specialist/ Pharmaceutical

Type: Permanent

Location: Bolton

Salary: £35,000 - £40,000 DOE

Our Client, a well known pharmaceutical manufacturer is growing and looking to bring in an experienced Validation Specialist who will play a key role in some of the new equipment qualification, process validation and analytical method validation plans/ implementation.

The Role:

  • Execute Equipment Qualification activities in line with Annex 15. Prepare associated documentation, ensuring these are approved as per project timelines and site procedures.
  • Execute Process Validation activities such as writing of Process Validation Plans, Protocols and reports.
  • Using recognized statistical techniques for process validation to demonstrate process control and process capability
  • Execute Cleaning Validation activities such as calculation of MACO values and writing of associated documentation, ensure these are approved as per project timelines and site procedures.
  • Liaise across departments and communicate new validation requirements as the facility continues to grow
  • Ensure Process/Equipment Validation activities are executed in line with business requirements, including the supervision of vendors or contracted staff where applicable.
  • Comply with company Policies, Standard Operating Procedures (SOP's), and GMP at all times, maintaining inspection readiness.
  • Conducting service works directly relating to Environmental Monitoring, Validation and Temperature Mapping.
  • Complete PQS documentation such as change control, CAPA and deviations relating to validation activities
  • Management and control of service equipment ensuring equipment is maintained, checked and returned.
  • Completing on-site system commissioning & training
  • Prioritisation of time management to ensure deliverables are achieved in a timely manner.
  • Providing on site customer support, technical advice and troubleshooting where necessary.
  • Preparation and execution of paperwork for service and calibration works.

The Person:

To be successful in your application to this exciting opportunity as the Validation Specialist we are looking to identify the following on your profile and past history:

  • Relevant degree in a Scientific or Engineering discipline
  • Proven industry experience working as a Validation Specialist / Process-equipment Validation Specialist / Process Engineer / Quality Validation Engineer
  • Proven industry experience having completed equipment qualifications, test method validations and Cleaning validations.
  • Experience of applying statistical techniques to validation activities

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