Process Engineer
GlaxoSmithKline
- Cambridge
- Permanent
- Full-time
- Work independently to drive/own and cross functional team performance.
- Develop a strong understanding of the manufacturing process and details of the associated hands-on operating requirements.
- Learn complex concepts and communicate the information in a way that is engaging and understood by users.
- Collaborate closely with SMEs and QA teams to create clear, concise, and technically accurate documentation.
- Perform all tasks associated with Quality Record Management and Initiation and collaboratively resolve issues.
- Own and manage Manufacturing process specific change controls, and CAPA’s.
- Author Minor and Major Deviation Investigations.
- In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools.
- Devises and implements CAPAs to address root cause and ensure effectiveness.
- Collaborate with technical and operational stakeholders, writes and/or revises SOPs, batch records, technical reports, and other operational related documents if required.
- Generate training material and conduct training for manufacturing staff.
- Execute and collaborate with MFG and cross functional SMEs on Human Error Reduction CAPAs/Right First Time Initiatives.
- Drive and own improvement projects that support department KPI’s, with a focus on cost, innovation, on-time delivery, and quality. Manage projects from concept to completion; create and manage project plan, work cross- functionally and provide adequate training to impacted areas.
- Generate and Manage Metrics.
- Act as back-up to Manufacturing Management to perform Validation Protocol Review and approval.
- Support the implementation of new processes in close collaboration with Program Managers, Process Transfer/Process Development, Engineering, MSAT, QA and Validation team.
- Identify new technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed.
- Collaborate with engineering and validation teams to implement and qualify new equipment and controls.
- Represent the interests of the Manufacturing team, serve in multidisciplinary project teams, working closely with other team members in a cooperative fashion to ensure project progression.
- Be actively engage in Inspection Readiness activities and support internal and regulatory audits as needed.
- Adhere to cGMPs is always required during the manufacture and release of APIs. All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner for serious GMP deficiencies, process deviations, product defects and relevant actions.
- Perform other duties and projects as assigned, according to the changing needs of the business.
- BS Degree in Engineering or equivalent technical discipline
- 3+ years of Biotech/Life Science/Pharmaceutical Biologics GMP Manufacturing related experience is required.
- Facilitation and demonstration skills
- Independent collaboration with outside resources
- More advanced knowledge / proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP) General knowledge of Quality/Regulatory GMP requirements in a biologics Pharma/ Biotech industry.
- The knowledge, understanding, and application of cGMP’s as it relates to Commercial operations.
- Excellent written (especially technical writing), presentation and verbal communication skills.
- Superior planning, time management and coordination skills and be able to readily adapt to changes in priorities and project schedules.
- Attention to detail and good investigation, problem-solving skills.
- Prioritize and deliver work in a fast-paced, deadline-driven environment.
- The ability to adapt rapidly to a changing industry and be able to adjust responsibilities, time, and objectives accordingly.
- Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint.
- Very strong attention to detail.