Product Validation Engineering Manager
Flock SafetySalary not specified
Validation Project Manager (Compounding) at Baxter International
Thetford, England, United Kingdom
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Pharmaceuticals, ManufacturingIndustries
Requirements
- Scientific/Engineering Degree or equivalent qualification or relevant experience within a validation role
- Working knowledge of validation in a pharmaceutical/FMCG/medical devices environment (preferably)
- Logical and practical approach to tasks with a proactive problem-solving mindset
- Analytical thinking and innovative problem-solving abilities to implement validation strategies
- Self-motivated and driven to complete projects/tasks efficiently and effectively
- Excellent teamwork skills and ability to communicate effectively with diverse teams
Responsibilities
- Ensure adherence to Site Validation Master Plan (SVMP) and conduct validation activities per protocols and procedures for equipment (may include occasional weekend work)
- Develop and implement validation documents and protocols for processes, equipment, facilities, and systems, emphasizing aseptic manufacturing
- Collaborate with validation team and other departments to implement new processes, products, and equipment, including creating Validation Plans (VP), User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Participate in assessment, review, and approval of changes impacting validation status, ensuring proper change control processes
- Review validation execution and equipment changes by external contractors and internal project teams for compliance
- Own project management and execution for Capital Expenditure and Process Improvement Projects in the EMEA Validation portfolio
- Work with Quality Assurance to address ad-hoc validation requirements
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What benefits are offered for this role?
Benefits include 25 days annual leave + bank holidays, subsided canteen, blue light card, employee discount scheme, Westfield healthcare, up to 8% pension contribution, and employee assistance programme.
Is this a remote position or onsite?
This is an onsite position at Thetford Compounding.
What are the main responsibilities or skills needed for this role?
Key responsibilities include ensuring adherence to the Site Validation Master Plan, developing validation documents and protocols for processes, equipment, facilities, and systems (especially aseptic manufacturing), collaborating with teams on new implementations, and reviewing changes and contractor work for compliance.
What is the company culture like at Baxter?
Baxter's culture is driven by courage, trust, and collaboration, with colleagues united by the mission to Save and Sustain Lives, empowering individuals to take ownership and deliver exceptional results.
What are the work hours and any flexibility?
The role is Monday-Friday with flexibility to work 08:00-16:00, 08:30-16:30, or 09:00-17:00, and may occasionally require a small amount of weekend work to support operations.
Baxter International
Provides essential medical products and services
About Baxter International
Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.
Deerfield, IllinoisHeadquarters
1931Year Founded
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
