25 Jun, 2021

Process Engineer

  • GSK
  • King of Prussia, PA, USA
Process Engineer Biochemicals / Pharmaceuticals

Job Description

Are you looking for an engineering role that allows you to leverage your technical knowledge in a state-of-the-art manufacturing environment?  If so, this Process Engineer role could be an ideal opportunity to explore.

 

As a Process Engineer, you will be responsible for providing ongoing engineering support to GMP Pilot Plant Operations in order to deliver R&D key clinical assets by participating in deviation investigations, change controls, and safety and compliance initiatives.

 

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

 

  • Leads investigations relating to equipment and facility issues, using effective deviation management techniques to help drive towards the identification of true root cause, identify corrective and preventative actions (CAPAs), and mitigate risk of repeat deviations
  • Supports technical change activities relating to new and existing products, equipment, processes and materials (transfers, qualifications and optimization activities) utilizing Change Control Procedures.
  • Performs risk assessments and Failure Mode Effect and Analysis (FMEA) for both quality and safety compliance.
  • Develops engineering specifications, policies, and procedures as required.
  •  Proficient at producing detailed engineering reports that provide viable and cost-effective alternatives for equipment or systems of moderate to complex design
  • Supports and actively participates in Management Monitoring Program (L1 self-inspection). Reporting findings and managing actions to closure.
  • Capable of generating and maintaining system life cycle documentation (Drawings, Design Files, FRS, SDDS, etc)
  • Support continual improvement activities by identifying projects to improve efficiency, reduce cost of poor quality, and reduce cost of goods.
  • Interact with internal and external auditors and regulatory agencies as needed during inspections. Provide support and review of Regulatory Documents.
  • Serves as the primary Process Engineering resource for evaluation, support and guidance in all areas and aspects of process operations including Microbial Fermentation, Cell Culture Fermentation, Purification, Solutions Preparation, and Clean Utilities Generation.

 

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

 

  • Bachelor’s degree in an engineering discipline.
  • Minimum of 2 year of industry experience within a manufacturing environment.

 

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

 

  • Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements preferred.
  • Good written communication, organizational, and computer skills. Good interpersonal and leadership skills required. Able to function in a team-based organization.
  • Able to prioritize and decide appropriate course of actions. Effective at implementing decisions.
  • Excellent troubleshooting/problem analysis skills. Familiarity with Lean Sigma and Root Cause Analysis methodologies.
  • Effective time and energy management with an ability to clearly identify priorities and manage multiple tasks while working in a matrix team environment.

 

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

*LI-GSK

 

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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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