Senior GMP Operations Scientist
- Richmond, VA
Site Name: Richmond Sherwood
Posted Date: Nov 11 2020
The Senior GMP Operations Scientist is the technical and engineering expert within the Pilot Plant, providing technical leadership and support for equipment and facility-related activities (installation, qualification, cleaning, operation), and process related activities (documentation, batch manufacture).
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Prepares and executes equipment life cycle activities for equipment and systems within the GMP pilot plant (specification, purchase, installation, qualification, validation, etc)
- Coordinates equipment training activities for operators and scientists in the pilot plant
- Interfaces with R&D scientists/engineers to identify their needs for upcoming projects in the pilot plant, and ensures equipment is suitable
- Provides technical leadership and support to project teams during manufacture of product within the pilot plant.
- Identifies and drives technical/process improvement opportunities within the pilot plant
- Develops and executes cleaning validation activities within the pilot plant
- Provides technical support and troubleshooting assistance for all equipment and systems within pilot plant
- Interfaces with external vendors and service providers to arrange equipment demonstrations, troubleshooting, and repairs
- Ensures all work is conducted in accordance with written procedures (e.g. quality and safety), methods & batch documents, etc.
- Identifies, challenges, develops and implements written procedures (e.g. quality and safety) methods & batch documents, etc.
- Produces or contributes to, departmental quality documentation (including SOP's, batch documentation, validation protocols & reports).
- Supports specific safety and quality responsibilities for department and site (e.g. GMP, Audits, Health & Safety).
- Delivers all EHS standards and expectations on site and within the pilot plant, including development of suitable risk assessments for pilot plant equipment and activities.
- Maintains awareness of scientific literature to assist work progression and understanding.
- Highlights own training needs and, working with manager, develops a training plan and achieves training goals.
- Trains self and others in new technology and laboratory responsibilities (including coaching, mentoring and elements of personal development).
- Develops knowledge of regulations impacting areas of work (e.g. EP/USP/ICH, FDA, DEA, OSHA)
- Builds relationships with cross-functional partners to deliver shared goals
- Ensures all work is always conducted following good scientific practice and Good Manufacturing Practice.
- Flexes priorities to remain focused on objectives in rapidly changing circumstances.
- Takes responsibility for specific equipment in accordance with site procedures.
- Participates and may lead in general problem solving, or leads specific problem solving initiatives
Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree in Engineering, Pharmaceutical or related science
- 5+ years prior experience in the pharmaceutical or consumer healthcare industry, specifically in pilot plants, validation, or engineering.
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- Ability to apply scientific principles and techniques to assigned projects.
- Knowledge of R&D process and associated commercial environment.
- Clear communicator in both oral and written form with both internal departments and external organisations.
- Demonstrates ability to take initiative, think and work independently, problem-solve, work effectively in teams, and multitask.
- An ability to organise and report data from internal and external sources.
- Flair for creativity and innovation
- Computer literate.
- Basic understanding of statistics and its application to experimental work.
- Functional awareness of Operational Excellence and Lean Sigma tools
Why GSK? 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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