11 Jan, 2021

Process Engineering Lead

  • GSK
  • New York, NY, USA
Process Engineer   Biochemicals / Pharmaceuticals

Job Description

Process Engineering Lead


Lead and manage all Technical activities and direct reports for the assigned products and/or areas. This includes, serving as the single point of contact for assigned products, ensuring the performance of all GSK products are monitored and maintained in a validated state, supporting root cause investigations by providing CH Technical intelligence to deviations, technical complaints, OOS & CAPAs, identifying and executing continuous improvement opportunities, supporting New Product Launch technical teams and supporting technical activities related to Technical Transfers to the site.


The Process Engineering Lead will support the Oak Hill site by leading initiatives and/or work-streams and representing Technical in various activities. Supervise and provide leadership to direct reports supporting critical manufacturing and packaging processes and/or transfers.


The Process Engineering Lead acts as the technical process lead for their assigned area(s) and provides direct supervision, assistance, guidance, and leadership to their technical team. He/she ensures holistic technical oversight of the activities of their assigned products, areas or projects.


Key Performance Indicators (Indicate how performance for this role will be measured)

  • Positive trends in KPIs, e.g., injury rates, year-on-year, reduction in deviations due to team projects.
  • Feedback from customers indicative of timely, actionable and cost –effective solutions.
  • No non-compliance with respect to safety and environmental regulations.  
  • Timely, accurate completion of inspections, audit response plans and reports.
  • Adherence to site environmental compliance calendar.


Technical Support and Oversight

The Process Engineering Lead ensures that GSK products are manufactured and packaged with appropriate technical support. Major accountabilities include:

  • Development and oversight of technical process support team, and to develop and maintain KPIs to measure the progress of the team’s deliverables.
  • Ensuring critical manufacturing and packaging processes/areas have appropriate technical oversight
  • Assessing impact of manufacturing and packaging changes
  • Identifying process optimization/continuous improvement opportunities and executing them as approved
  • Providing Technical intelligence to deviations, investigations, and OOS’, technical complaints
  • Defining, tracking, and completing technical CAPAs resulting from Product Periodic Reviews (PPRs), manufacturing/ packaging variances and/or deviations
  • Providing Technical intelligence to PPRs and delivering the performance capability results, interpretations and recommended CAPAs
  • Assist in product validation strategies including approval of Technical Risk Assessments and similar assessments, validation protocols, and reports
  • Establishing and executing continued process verification strategies
  • Ensuring maintenance of knowledge for the manufacturing of GSK products
  • Assist on product launch/transfer activities to ensure future sustainability
  • Identify opportunities and implement changes to improve products and processes or reduce costs using knowledge of manufacturing processes
  • Provide technical process support and expertise for the scale up and/or transfer in of new products and/or process changes due to materials, equipment, or other environmental factors.
  • Effectively contribute to the successful achievement of safety, quality and production goals and metrics through excellent technical process support and problem solving.
  • Consistently demonstrate subject matter expertise on the unique characteristics of the assigned processes.
  • Product lifecycle management


EHS Responsibilities – All Associates

  • Know, understand and comply with all Health, Safety and Environmental (EHS) guidelines
  • Report unsafe conditions
  • Report all injuries, illnesses and hazardous materials releases
  • Wear personal protective equipment
  • Attend EHS training programs
  • Follow all safe work procedures


Directors, Associate Directors, Managers, Supervisors, Team Leaders.

Line management is responsible for providing a work environment free from recognized hazards and compliance with all applicable laws and regulations.  Specific EHS responsibilities may include:

  • Maintain the department’s EHS programs and encourage associate involvement.
  • Ensure compliance with company guidelines and procedures.
  • Report EHS statistical performance of their departments Investigate and report on all injuries, illnesses, hazardous materials releases, and near misses.
  • Identify and implement corrective actions for findings associated with EHS audits.
  • Ensure that employees in their departments receive appropriate EHS training.
  • Ensure that adequate engineering controls are instituted and being used to control hazards. Ensure that identified administrative controls are being utilized.
  • Ensure that associates are trained in emergency procedures. Identify and train individuals responsible for performing risk analysis for their areas.
  • Provide resources and personnel necessary to conduct EHS activities.
  • Facilitate department safety meetings.
  • Provide written safety communications to associates.


Why you?


Basic Qualifications:


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

  • BS in a scientific, engineering, or applicable technical discipline
  • Minimum 5 years of experience working in a regulated manufacturing environment; preferably manufacturing of consumer goods, pharmaceuticals, petrochemical, commodity chemicals or specialty chemicals
  • Experience leading teams, both line and matrix, to deliver results in a STEM field
  • Experience process validation concepts and thorough understanding of GMP documentation requirements to support equipment, process or material changes
  • Experience with industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA, EMEA, Health Canada, etc.)


Preferred Qualifications:


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

  • Excellent knowledge of English
  • MS in Science, Engineering or equivalent STEM field, Project Management
  • Strong project management, interpersonal, cross-cultural, communication, negotiation and problem-solving skills
  • Project management skills and experience on major technical/engineering projects
  • Ability to use and interpret data to drive decision making at both tactical and strategic level
  • Time management skills, ability to manage conflicting priorities
  • Resource management
  • Detailed knowledge of operational excellence tools e.g. FMEA, MSA etc
  • Demonstrated attention to detail and data accuracy
  • Demonstrated problem solving and decision making skills
  • Strong communication, negotiating and influencing skills
  • Strong numeracy, literacy, analytical skills, including technical report writing
  • Solid knowledge of internal and external quality and EHS requirements


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:


  • Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.





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