Biopharm Process, Control and Automation Engineer

Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Biopharmaceuticals Manager role could be an exciting opportunity to explore.

The purpose of this job is to drive activities in the Biopharm AMT (Advanced Manufacturing Technologies) workstream business plan. The AMT group was created to deliver GSK's Manufacturing Technology Roadmap with the global objective to transform the way GSK manufacturers its pharmaceutical products over the next 5-10 years. The Biopharm workstream of the AMT group has identified a portfolio of new technology platform opportunities with the potential to transform biopharmaceutical development and manufacturing within GSK. The purpose of this position is to support the development of new technologies with the potential to transform biopharmaceutical development and manufacturing within GSK in the subject matter areas related to Cell Line & Cell Culture/Fermentation, Purification, Formulation and Process Analytical Technologies.

In this role, you are the technical expert and leader for all process engineering, instrumentation and control systems that support the incubation of a novel manufacturing platform exploring the principles of continuous processing for biologics manufacture. The role in the R&D Platform Technologies and Science, Biopharm work stream of the Advanced Manufacturing Technology (AMT) organization, will help drive projects; quickly working out what needs to be done, who needs to be connected, and executing the work with top tier compliance and efficiency. The role will support delivery for the reliability, maintenance, performance improvement and compliance of the automation infrastructure for this manufacturing platform.

THE SPECIFIC DUTIES OF THE ROLE/POSITION:

• Lead the installation and ad hoc modifications of instrumentation and control systems including Delta V, Beckhoff controllers, Allen Bradley SCADA, and utility PLC's

• Interface with the GSK IT department to ensure all necessary components and interfaces are aligned and that additional IT and data technologies and tools are able to communicate with the system

• Troubleshoot and correct problems with instrumentation and control systems and develop / optimize operation and maintenance procedures as well as training programs for control systems as required

• Experimentally evaluate different technologies at bench scale for their potential use in development. Includes initial process screening, optimization and characterization, and potential scale-up.

• Design experiments, interpret results, and communicate findings (presentations and reports)

• Support the development of validation documentation and implement validation plans for instrumentation and control systems as required

• Interface with users, peers, and management to ensure appropriate input and integration of local and corporate standards

• Stay current on developments in the field of instrumentation and control technologies and identify potential improvement projects and support the business case for investment to management

• Manage vendors and consultants to ensure that contracts meet scope and budget

• Work with other plant operations, engineering, and product / process development teams to implement and maintain automation systems, execute projects and communicate the status effectively

• Support system life-cycle documentation for automated control systems, such as, Functional Specification (FS), Software Design Specification (SDS) and control wiring diagrams

Why you?
Basic:

• Bachelors in any of the following: Engineering, Life or Physical Sciences or equivalent

• 3+ years relevant working experience in a process control function

• Familiar with GMP operations and working in an FDA regulated environment

• Understanding of process controls principles to equipment, instrumentation, and networks to troubleshoot automation related problems

• Familiar with Emerson DeltaV control systems, Allen-Bradley PLC's, OPC and Industrial I/O communications, S-88 control standards, and hazardous area and IP65 rated computing equipment

• Capable of maintaining system life cycle documentation (Drawings, Design Files, FS, SDS, etc), familiar with executing controlled changes in a GMP environment

• Experience validating computerized systems including protocol generation and execution.

• Demonstration of experience in basic laboratory activities, process control and automation, continuous, semi-continuous and batch processing modes

• Basic understanding of biopharmaceutical laboratory and manufacturing processes including cell culture/fermentation principles, purification techniques and Process Analytical Technology (PAT) concepts

• Excellent written and oral communication skills

• Demonstrated experience successfully completing a detail oriented project.

Preferred

  • Advanced Degree in any of the following: Engineering, Life or Physical Sciences or equivalent
  • 6+ years relevant working experience in a process control function
  • Relevant working experience in a process control function in a pharmaceutical manufacturing environment

• Previous research experience or internship experience in biopharmaceutical industry

• Strong understanding of protein purification, microbiology, protein chemistry and PAT

• Experience with routine sensors, probes and analytical measurements (online / at-line / off-line monitoring of processes)

• Enthusiastic, flexible and results-oriented person who likes the challenge of working with a variety of teams in a multi-tasking environment

• Adaptable to a wide variety of laboratory/hands-on activities

• Experience with other typical biotechnology/biopharmaceutical unit operations

• General understanding of equipment, utilities and processes used in biopharmaceutical manufacturing

• Ability to work in cross functional teams

• Proven ability to analyze technical situations and recommend improvements

• Capable of supervising the activities of contractors; Capable of assembling project budgets

• Maintain and document all cGMP equipment/system modifications and upgrades through approved change control methods as required

• Support timely completion of quality investigations and corrective and preventative actions as required

• Contribute to the ongoing development of colleagues

Why GSK?

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.


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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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