Senior Validation Engineer - DeltaV
- King of Prussia, PA
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Apr 10 2020
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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
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.
Basic Qualifications: 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.
- 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.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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