Validation Engineer/Senior Validation Engineer

Are you looking for an opportunity to manage projects, identify areas of improvement, and support safety working practices? If so, this is the job for you.

As a Validation Engineer/Senior Validation Engineer, you will be responsible for

the creation of Validation Strategy; preparation and execution of Installation Qualifications, Operational Qualifications, Performance Qualifications and Process Validation which are harmonized with this division's corporate standards.

This position will also be required to contribute to the development of Site Validation Master Plans. This position will support all validation activities with focus on the aseptic filling areas with qualification associated with manufacturing equipment, including autoclave, washer, tunnel, Sterilization in Place of filling vessels and cleaning validation.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Support all aspects of the Validation Life Cycle in Manufacturing from design through operation and improvement as required.
• Author and execute IOQ and PQ protocols and reports for equipment and computerized systems in production, QC and storage areas on site.
• Provide key technical review for the Marietta Site with respect to SOP development and provide technical input for change control in order to assure that site needs are addressed and compliance and industry standards are incorporated.
• Author, review or revise Standard Operating Procedures (SOP's) as required.
• Responsible for the site requalification plan execution and implementation.
• Streamline testing requirements while maintaining regulatory and corporate compliance.
• Responsible for the preparation of site validation documentation such as qualification protocols, validation master plans, risk assessments, periodic reviews.
• Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies.
• Participate on cross-functional teams, including value streams and site support groups to address specific problems, facilitate discussion and research and enable procedures to become more efficient.
• Build and enhance interdepartmental relationships. Implement improvement initiatives with filling/packaging and facility/utility qualification activities.
• As the site validation representative, present information or answer questions to regulatory agencies during the audit process regarding the validation program and specific validation studies.
• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, and standard operating procedures.

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's Degree
• Minimum 2 years' pharma and practical experience related to validation of equipment and systems
• Minimum 2 years' experience writing, execution and review of IQ/OQ/PQ preferably with knowledge of secondary process equipment

If you have the following characteristics, it would be a plus:

• Bachelor's degree in science, chemical engineering, or life sciences
• Familiarity with Good Manufacturing Practices
• Must have demonstrated self-direct work habits and strong communication skills.
• Must be a committed team player prepared to work in and embrace a team based culture.
• Ability to work in a high complex matrix environment.
• Maintain a high level of integrity while balancing multiple priorities and responsibilities.
• Sense of urgency, flexibility and accountability.
• Ability to follow written procedures and document results in a neat and precise manner.
• Intermediate computer skills.
• Stay current on developments in the field and GSK Vaccines Standards.
• Maintain attention to detail, while completing multiple or repetitive tasks.
• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.

We are also looking for more experienced individuals for our Senior Validation Engineer role. The qualifications for this role at our site are listed out below:

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree
• Minimum of 5 years' pharmaceutical experience in validation preferably with knowledge of secondary process equipment to support aseptic filling.
• Minimum of 5 years' prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ) required.
• SME experience in any 3 of the following areas is required:
  • Sterilization Validation
  • Equipment Validation
  • Cleaning Validation
  • Process Validation
  • Validation of Aseptic Processing
  • HVAC, Smoke Studies and EM Qualification

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Post Graduate Degree.
• Experience in preparing validation master plans.
• Familiarity with Good Manufacturing Practices
• Must be able to provide leadership to generate options, resolve problems, prioritize solutions, select optimal solutions and implement decisions.
• Must have demonstrated self-direct work habits and strong communication skills.
• Must be a committed team player prepared to work in and embrace a team-based culture.
• Familiarity with regulatory expectations regarding electronic records and electronic signatures.
• Ability to work in a high complex matrix environment.
• Sense of urgency, flexibility and accountability.
• Ability to follow written procedures and document results in a neat and precise manner.
• Intermediate computer skills required.
• Stay current on developments in the field and GSK Vaccines Standards.
• Maintain attention to detail, while completing multiple or repetitive tasks.
• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
• Maintain a high level of integrity while balancing multiple priorities and responsibilities.

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Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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