Downstream Manufacturing Support Engineer
Downstream Manufacturing Support Engineer
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Job Description
About PSC Biotech
Who are we
PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.
Work as a key team member within the Downstream (DS) Integrated Process Team (IPT) to ensure ontime delivery of the production schedule while maintaining alignment with site safety and quality standards.
Provide oversight on material management ensuring quality and delivery metrics related to material management are always maintained.
Own Quality Investigation from identification through root cause analysis
Provide oversight on daytoday production quality metrics ensuring ontime documentation closure line clearance and material management as per area SOPs.
Drive continuous improvement projects related to schedule equipment and delivery capability within the DS IPT.
Act as a link between the shift operations team and days team ensuring stardardisation and integration between all IPT teams.
Support audit readiness in the BDS and drive a permanent audit readiness culture within the team.
Direct Root Cause Analysis (RCA) sessions for both safety and quality related events driving actions to closure with appropriate corrective/preventive measures.
Lead/support area change controls CAPAs QSAT actions as relevant per work stream as well as completing documentation updates as required.
Provide ongoing coaching and support to cross functional team members to share process and operational best practices.
Role Functions
Role Functions
Requirements
Key Competencies & Experience:
A Level 7 Degree in Science Engineering or other relevant disciplines/ relevant experience preferable
Experience in change management in a GMP environment.
Experience in technical writing for GMP documentation and quality investigations.
Selfmotivated with excellent organizational skills
Excellent verbal and written communication skills
Proficient in Microsoft Office Tools (word/excel/PowerPoint )
Ability to work independently and as part of a team in a cross functional collaborative environment.
High level of attention to detail
Experience working with GMP Documentation Management Systems
Good interpersonal skills
Qualifications:
Work as a key team member within the Downstream (DS) Integrated Process Team (IPT) to ensure on-time delivery of the production schedule while maintaining alignment with site safety and quality standards. Provide oversight on material management, ensuring quality and delivery metrics related to material management are always maintained. Own Quality Investigation from identification through root cause analysis Provide oversight on day-to-day production quality metrics ensuring on-time documentation closure, line clearance and material management as per area SOPs. Drive continuous improvement projects related to schedule, equipment, and delivery capability within the DS IPT. Act as a link between the shift operations team and days team, ensuring stardardisation and integration between all IPT teams. Support audit readiness in the BDS and drive a permanent audit readiness culture within the team. Direct Root Cause Analysis (RCA) sessions for both safety and quality related events, driving actions to closure with appropriate corrective/preventive measures. Lead/support area change controls, CAPAs, QSAT actions as relevant per work stream as well as completing documentation updates as required. Provide ongoing coaching and support to cross functional team members, to share process and operational best practices. Act as days operations member on process centered teams (PCT), working with technical operations and shift operations to identify, perform root cause analysis and develop corrective/ preventative actions for issues as they are occur.
Education
Work as a key team member within the Downstream (DS) Integrated Process Team (IPT) to ensure on-time delivery of the production schedule while maintaining alignment with site safety and quality standards. Provide oversight on material management, ensuring quality and delivery metrics related to material management are always maintained. Own Quality Investigation from identification through root cause analysis Provide oversight on day-to-day production quality metrics ensuring on-time do
Employment Type
Full Time
