Engineer, Validation in Stockport

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

Baxter Healthcare Ltd North West Compounding is currently seeking an experienced Validation Engineer to join our team on site. Our company is dedicated to upholding a seamless validation process for our manufacturing facility, equipment, processes, and systems. As a Validation Engineer, you will have a vital role in ensuring our site adheres to Good Manufacturing Practices (GMP) and regulatory standards. You will collaborate closely with a diverse team, allowing you to gain exposure to various areas of our organisation. This unique aspect of the role offers exceptional prospects for career progression within our world-class company.

Duties & 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 and a variety of equipment. (Sometimes to support the operational status of the facilities there may be a small amount of weekend work)
• Develop and implement validation documents and protocols for a variety of processes, equipment, facilities, and systems, with a particular emphasis on aseptic manufacturing.
• Work closely with the validation team and teams from various departments to assist with the implementation of new processes, products, and equipment at the site. This involves developing detailed documentation, including Validation Plans (VP), User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Actively participate in the assessment, review, and approval of changes that may impact the validation status of our facilities, equipment, processes, and systems. This involves ensuring the correct operation of our change control process.
• Conduct thorough reviews of validation execution and equipment changes carried out by external contractors and internal project team members 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.
• Work with Quality Assurance to react to adhoc validation requirements.

The ideal candidate would also be able to support validation activities across all UK Compounding sites.

What experience are we looking for?

• You will have a Scientific/Engineering Degree or equivalent qualification or the right experience within a validation role.
• Experience working with Hydrogen peroxide decontamination systems.
• In depth knowledge of a specific validation/engineering skill set. I.e. temperature mapping, airflow and smoke visualization, Biological Indicator application and processing etc.
• You will be able to demonstrate working knowledge of validation in a pharmaceutical/FMCG/medical devices environment preferably.
• Experience with Equipment/Process systems, Cleaning Validation, HVAC, QA, QC, or Cleanroom systems would be preferred.
• Approach tasks with a logical and practical perspective, and have a proactive approach to problem-solving.
• Display analytical thinking and innovative problem-solving abilities to successfully implement validation strategies.
• Self-motivated and driven to complete projects/tasks efficiently and effectively.
• Excellent teamwork skills to contribute effectively as a member of a diverse team and effectively communicate with individuals involved in the project.

What are some of the benefits of working at Baxter?

• Competitive total compensation package
• Professional development opportunities
• High importance placed on work life balance

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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