The Senior Validation Engineer will be responsible for equipment/facility validation projects in a hands-on role including writing validation protocols, completing data sheets, scheduling and performing validation tests, gathering and analyzing data, and writing final validation reports.
- Identify systems requiring validation (specifically computer validation). Lead the development of required validation procedures and practices with respect to the facility. Develop validation project/assignment detailed schedules to coincide with the milestones on the master plan.
- Design and implement required validation studies and protocols for the facility and equipment as per required schedules.
- Coordinate and lead resources required to complete validation studies and tests in a timely manner.
- Mentor and train junior validation team members.
- Develops project timelines, maintains team schedules, and communicates progress on projects.
- Analyze test data. Lead and document investigations of failed validation test results.
- Develops, coordinates and implements the computer/control systems, laboratory, equipment, utilities/facility, and cleaning validation efforts.
- Maintain validation documentation program and appropriate control procedures.
- Provide validation leadership in the design and qualification of new systems and modifications to existing systems to ensure designs comply with current validation standards and are able to be adequately validated and maintained within validated control.
- Identify and lead the implementation of required updates to procedures, practices, and policies related to validation, equipment and processes.
We are looking for professionals with these required skills to achieve our goals:
- Associate degree in a technical discipline.
- 7 years of relevant experience
- Computer System Validation experience – analytical equipment, IT systems, and/or control systems
- Hands-on technical experience, experience leading projects and team
- Knowledgeable in cGMP’s, GAMP, and data integrity requirements.
- Must be computer literate – specifically Microsoft Windows operating system settings and configuration, control systems (DeltaV), databases, etc.
- Must be familiar with established documentation practices for validation programs.
If you have the following characteristics, it would be a plus:
- BS/BA in engineering or life sciences, or equivalent technical discipline
- 5 years of relevant experience
- Strong technical understanding of the industry and validation practices related to the pharmaceutical industry.
- Strong verbal and written communication skills.
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
As a global healthcare company, we take on some of the world’s biggest healthcare challenges. By delivering a sustainable business, we provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
We are committed to widening access to our products, so more people can benefit, no matter where they live in the world or what they can afford to pay. Each of our three businesses benefits from GSK’s commercial infrastructure, integrated supply networks and significant global presence.
As a global company, our reward packages are designed to meet the needs of our geographically diverse workforce. They are benchmarked against industry standards and relevant to your job, no matter where you live.
Our reward package includes:
- A competitive base salary
- An annual bonus that rewards you for your individual contribution to our strategy, as well as business targets
- Benefit programs designed to support you and your family, including access to healthcare and well-being programs, pension plan membership, savings programs, time off and childcare support
- Employee recognition programs which reward exceptional achievements
- Share ownership schemes which link your reward to GSK’s longer term performance
- A performance and development program that helps you identify what you need to do, and the behaviors you need to demonstrate, to achieve success.