Validation Project Manager (Compounding)

Baxter; Tetford; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading pharmaceutical company in Tetford is seeking a Validation Specialist to ensure compliance with validation activities. The role involves developing protocols, collaborating with teams, and managing validation projects. Ideal candidates are detail-oriented and possess a scientific or engineering background. This position offers excellent career progression and various employee benefits including flexible working hours and educational support.

Benefits

Support for Parents

Continuing Education/ Professional Development

Employee Health & Well-Being Benefits

Paid Time Off

25 days annual leave + bank holidays

Excellent career progression opportunities

Employee assistance programme

Qualifications

• Demonstrated working knowledge of validation in pharmaceuticals preferred.
• Self-motivated and driven to complete projects efficiently.
• Courageous, collaborative, critical thinker.

Responsibilities

• Ensure compliance with Site Validation Master Plan.
• Develop validation documents and protocols.
• Collaborate with the validation team on new processes.
• Manage validation-related projects and changes.
• Review validation execution and contractor work.

Skills

Detail oriented

Analytical thinking

Excellent teamwork

Communication skills

Problem-solving mindset

Education

Scientific/engineering degree or equivalent qualification

Job description

Responsibilities

• Ensure Site Validation Master Plan (SVMP) is strictly adhered to and that all validation activities are conducted in accordance with established protocols and procedures by executing validation work on a variety of equipment. Some weekend work may be required to support operational status of facilities.
• Develop and implement validation documents and protocols for a variety of processes, equipment, facilities, and systems, with a particular emphasis on aseptic manufacturing.
• Collaborate with the validation team and cross-functional departments to implement new processes, products, and equipment at the site. Develop detailed documentation, including Validation Plans (VP), User Requirements Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Assess, review, and approve changes that may impact the validation status of facilities, equipment, processes, and systems, ensuring proper operation of the change control process.
• Review validation execution and equipment changes carried out by external contractors and internal project teams to ensure compliance with validation requirements.
• Take ownership of project management and execution for Capital Expenditure and Process Improvement Projects within the EMEA Validation project portfolio.
• Collaborate with Quality Assurance to respond to adhoc validation requirements.

Qualifications and Attributes

• Detail oriented
• Continuous learner
• Courageous, collaborative, critical thinker, and influential with a scientific/engineering degree or equivalent qualification or relevant experience in a validation role.
• Demonstrated working knowledge of validation in a pharmaceutical, FMCG, or medical devices environment preferred.
• Ability to approach tasks logically and practically with a proactive problem-solving mindset.
• Analytical thinking and innovative problem-solving abilities to implement validation strategies.
• Self-motivated and driven to complete projects efficiently and effectively.
• Excellent teamwork and communication skills to contribute as a member of a diverse team.

About the Role

This role is part of the Baxter Quality team, aimed at supporting a seamless validation process for manufacturing facility, equipment, processes, and systems. You will collaborate with a diverse team and gain exposure to various areas of the organisation, offering potential for career progression within the company.

Benefits

• Support for Parents
• Continuing Education/ Professional Development
• Employee Health & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer
• Working hours: Monday-Friday with flexibility to 08:00-16:00 / 08:30-16:30 / 09:00-17:00
• 25 days annual leave + bank holidays
• Subsided canteen
• Excellent career progression opportunities
• Blue light card
• Employee discount scheme
• Westfield healthcare
• Up to 8% pension contribution
• Employee assistance programme