Are you looking to enhance your technical capability by working in a global manufacturing environment that allows you to leverage best in class systems and technologies? If so, this Process Engineer role could be an ideal opportunity to explore.
As a Process Engineer you will be responsible for ensuring delivery of clinical and developmental drug product within the Upper Providence oral solid dose pilot plant.
This role will provide the opportunity to lead key activities to progress your career. These responsibilities include some of the following:
- Support equipment introduction into a GMP oral solid dose pilot plant and ancillary support areas.
- Delivery of key safety processes within the pilot plants including process hazard assessments, risk assessments associated with new process/product introduction, investigation of safety incident/near misses, after actions reviews, etc.
- Management of equipment capital projects from specification through introduction into the facility.
- Ensuring readiness of equipment/ unit operations within the pilot plant.
- Deliver equipment repairs working with GSK's service partners (CBRE) and/or coordinating with external equipment suppliers.
- Training of operational staff on equipment operation and setup.
- Ensure equipment is available for use in support of development activities or clinical manufacturing.
- Act as the client representative for facility capital projects delivered through GSK's 3rd party service provider (Arcadis). Ensure that the pilot plant's needs are incorporated into the design and the installation of new pilot plant facilities and equipment.
- Ensure that all modifications, equipment rentals, new equipment purchases are tested and are suitable for use prior to any plant production activities.
- Coordinates repairs to PPO process equipment.
- Maintain facility compliance through generation of change control documentation associated with engineering changes in the plant.
- Contributes/participates in root cause analysis sessions in support of quality deviations, equipment issues, and incident reporting.
- Generation of user requirements for new equipment introduction.
- Supports equipment qualification activities by authoring initial user requirements and executing or authoring subsequent deliverables associated with equipment validation lifecycle (IOQ,DR, RTM etc).
- Provide direction to maintenance personnel during equipment preparation.
- Assess process unit operations and provide the necessary feedback to the pilot plant, PD scientists, and manufacturing to ensure processes are successfully executed.
- Attend pre-run meetings prior to plant campaigns to communicate unit operations issues to plant personnel.
- Provide Process Engineering expertise to EH&S risk assessments
- Facilitates PHA/ HazOp sessions and provides engineering expertise pertinent to the topic.
- Maintain an efficient communication process with customers and key stakeholders.
- Identify and evaluate useful available technologies that can improve the efficiency of the pilot plant network.
- Work closely with process safety to assist in detailed engineering evaluations based on process safety data
- Deliver maximum knowledge value to NCE projects through implementation of PAT and collection of data through existing DCS/ SCADA/ ASPEN IP21 infrastructure.
- Supports compliance related activities such as SOP authorship, CAPA completion, instrument out of tolerance/specification evaluations, global engineering alerts, etc.
- Drive continuous improvement by actively identifying efficiency, safety and quality improvement opportunities (i.e. via GEMBA) and providing engineering expertise and support during implementation.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in engineering
- 3 years of experience in GMP environment
If you have the following characteristics, it would be a plus:
- Experience working with oral solid dose manufacturing
- Experience managing or participating in capital projects
- Experience with commissioning and qualification principles.
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, 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 HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. 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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