- Missoula, MT
Site Name: USA - Montana - Hamilton
Posted Date: Oct 9 2020
As part of a team of manufacturing employees, you will support the start-up, definition of procedures, manufacturing of consistency batches, and sustained production of QS-21. This includes seeing a batch from raw materials to final shipped product, including, manual manipulations, automated manufacturing, cleaning of the facility, and review batch records.
- Support and promote the overall site goal of Safety First.
- Responsible for application of GSK safety and environmental guidelines and act as a role model within the department.
- Ensure all job responsibilities adhere with applicable regulations, current operating procedures and industry practice.
- Identify and help mitigate EHS and safety risks.
Process & Technical:
- Working with technical production equipment (e.g. HPLC and Lyophilizer). This includes interfacing with DeltaV automation to run the production equipment.
- Lead/support validation related to equipment, cleaning, and manufacturing processes
- Experience and competence in troubleshooting equipment and automation
- Perform manual operations including set-up/breakdown of filtration skids, filling/loading of lyophilization trays, loading equipment for cleaning, and routine sampling.
- Adherence to Good Documentation Practices as part of batch execution
- Ability to take ownership and accountability of their process/batch as they see it from raw material through final bulk packaging.
Communication & Teamwork:
- Excellent communication skills (written and verbal) within the team and across departments
- Supports cross-functional communication and the GSK quality mindset by proactively identifying and reporting compliance issues to area supervisor and QA.
- Actively participate in a high performing team, able to demonstrate initiative
- Ability to collaborate as part of a team and effectively work across boundaries including coordination with different departments.
- Drafting and revising Standard Operating Procedures
- Drafting and leading Change Controls for modifications to the procedures and processes
- Deviation writing, including root cause investigation and corrective action creation
- Perform and monitor manufacturing processes using a highly automated approach based upon Emerson's Delta V platform.
- Troubleshoot process deviations resulting from automation communication issues.
- Assemble batch reports using Emerson Delta V and OSI PI historian.
- Ability and drive to work independently toward completion of objectives per schedule
- Ensure all activities are executed following Quality and regulatory standards.
- Participate in and support continuous improvement and performance management initiatives.
- Drive and support GPS (GSK Production System) principles and initiatives
- Demonstrate a continuous improvement mindset to drive business impact
- Adhere to GSK values and expectations including: Patient Focus, Transparency, Respect, Integrity, Courage, Accountability, Development, and Teamwork
- Represent GSK with the highest level of integrity and professionalism.
- Ability to maintain confidentiality of sensitive information.
- Adhere to GSK policies and procedures and support management decisions and goals in a professional manner.
- Show awareness of changing schedules, request and priorities put forth by management.
- Adhere to GSK policies, procedures and support site goals.
- Participate in and support continuous improvement and performance management initiatives.
- Recognize technical issues and relay to supervisor.
- Perform duties as assigned with respect to quality, timeliness, quantity and cost
Why you? Basic Qualifications:
- Bachelor's degree or High School Diploma/equivalent (must have 4 to 5 years of cGMP/healthcare/lab related experience for this level of education)
- 1 to 3 years of cGMP/healthcare/lab related experience with Bachelor's degree or 4 to 5 years of cGMP/healthcare/lab related experience with High School Diploma.
- This manufacturing process is highly automated resulting in a significant amount of time being spent supporting investigations, deviations, corrective actions and refinement of team ways of working. These job functions require technical expertise resulting from either education or experience related to a highly scientific field as well as a sound understanding of GMP principles.
- Good oral and written communication skills. Ability to communicate effectively and project a professional image when giving/taking information in person, in writing, or over the phone.
- Understanding of Microsoft Office (MS Word, MS Excel, MS Outlook) as well as navigation within several automation platforms.
- Ability to take initiative and prioritize tasks; good time management, problem prevention, and problem-solving skills
If you have the following characteristics, it would be a plus:
- Bachelor's degree in Technical field such as Science discipline (i.e. Biology, Chemistry, etc.)
- The manufacturing line includes several highly technical process steps including HPLC, Ultrafiltration, Diafiltration, and lyophilization. Awareness of the technical principles related to these as well as experience with GMP and scientific writing will be required within these roles
- Experience with HPLC, UFDF, Lyophilizer, DeltaV Automation, and GMP activities
- Handling of hazardous waste from production activities to satellite storage areas. Annual training on area-specific hazardous waste handling as required. This training satisfies annual RCRA training requirement for large quantity generators as part of the site's RCRA compliance program
- Experience in participation in RCA (Root Cause Analysis) for EHS incident and deviations
- Able to participate in presenting and maintaining site in a state of inspection readiness
- Able to participate/write/close CAPA tasks both safety and quality related
- Able to ask for assistance and not perform duties without appropriate training
- Attend all mandatory training and take a positive approach to compliance
- Able to work collaboratively in a team environment as well as independently
- Able to work with minimal supervision and coordinate complex tasks between departments
- Adapt to changing schedules, priorities, and requests from supervisor
- Ability to independently operate production equipment per appropriate procedures
- Able to participate in all aspects of team functions
- Able to write and revise procedures/protocols
- Able to maintain MBRs, logbooks, Room History Record, and other paperwork
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:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor 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
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