USA - Missouri - St. Louis
Aug 10 2021
The Validation Engineer is responsible for the validation of new products, new equipment, including new computerized systems, new or revised Manufacturing and Packaging processes and Facility systems to support the manufacture of over the counter pharmaceutical and nutritional products to ensure each product is produced safely and with the identity, strength, quality and purity that it purports to possess.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Utilizing the GSK requirements and guidelines pertaining to the Validation Life Cycle and with adherence to all applicable Quality, FDA regulations, and Safety regulations, write and execute Installation Qualifications (IQs), Operational Qualifications (OQs), Performance Qualifications (PQs), Process Validations (PVs)/Process Characterizations (PCs), Cleaning Validations/Verifications, assist in spreadsheet validation protocols, Computer Validation (using GSK established methodologies i.e. iQMS), Continued Process Validation (CPV), coordinate validation executions with Engineering, Manufacturing, Packaging, and Quality and produce the subsequent Validation Reports of the executed protocols and perform Periodic Reviews of validated systems.
Assist System Owners (Operations, Quality) and Engineering to create User Requirement Specifications (URS) and Functional Specifications (FS), Design Specifications (DS), and other necessary design documentation, respectively, for GSK-St. Louis Systems;
Design and champion corrective and preventative action plans (CAPAs) and change controls (CCs) in accordance with the GSK quality management system.
Evaluate new equipment i. e. Factory Acceptance Testing (FAT) to ensure the equipment meets User Requirements;
Perform statistical analysis on the validation data generated and organize the data in tabular or graphical form;
Improve compliance by writing and/or revising Validation and related SOPs;
Participate in Operation Excellence (OE) initiatives, cross-functional teams, and special projects as required;
Complete internal and external Audit findings as assigned.
Ensure quality and compliance in accordance with established procedures and standards of the Quality System.
Comply with and support the GSK Environmental, Health and Safety policies and procedures.
We are looking for professionals with these required skills to achieve our goals:
Minimum of 2 years validation experience in the Pharmaceutical or Healthcare industry
Experience in cGMP regulations and validation guidelines
Experience in technical writing
If you have the following characteristics, it would be a plus:
Capable of working safely and complying with all safety regulations
Good communication, organizational and team skills
Familiarity with statistical sampling plans
Capable of working independently (and with a sense of urgency when necessary) with minimal supervision
Ability to work on multiple projects, ability to focus on the important projects and flexibility to adapt to changing priorities
Computer skills including Microsoft Word, Excel and Powerpoint
Computer validation experience
Statistical analysis skills
Green Belt certification or training
Our values and expectations are 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:
Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
Managing individual and team performance.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Implementing change initiatives and leading change.
Sustaining energy and well-being, building resilience in teams.
Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
Developing people and building a talent pipeline.
Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
Budgeting and forecasting, commercial and financial acumen.
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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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