Downstream Manufacturing Engineer

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Dublin
• State/Province Dublin
• Country Ireland

Job Description

About PSC Biotech

Who we are?

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 cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. 

Role Description:

Downstream Manufacturing Engineer working with DaysOperations support team.

Requirements

Role Functions:

· Work as a key team member within the Downstream(DS) Integrated Process Team (IPT) to ensure on-time delivery of the productionschedule while maintaining alignment with site safety and quality standards.

· Provide oversight on material management,ensuring quality and delivery metrics related to material management are alwaysmaintained.

· Own Quality Investigation from identificationthrough root cause analysis

· Provide oversight on day-to-day productionquality metrics ensuring on-time documentation closure, line clearance andmaterial management as per area SOPs.

· Drive continuous improvement projects related toschedule, equipment, and delivery capability within the DS IPT.

· Act as a link between the shift operations teamand days team, ensuring standardisation and integration between all IPT teams.

· Support audit readiness in the BDS and drive apermanent audit readiness culture within the team.

· Direct Root Cause Analysis (RCA) sessions forboth safety and quality related events, driving actions to closure withappropriate corrective/preventive measures.

· Drive MPS standards within the area and ensureteam alignment on same.

· Lead/support area change controls, CAPAs, QSATactions as relevant per work stream as well as completing documentation updatesas required.

· Provide ongoing coaching and support to crossfunctional team members, to share process and operational best practices.

· Act as days operations member on process centredteams (PCT), working with technical operations and shift operations toidentify, perform root cause analysis and develop corrective/ preventativeactions for issues as they occur.

· A Level 7 Degree in Science, Engineering orother relevant disciplines/ relevant experience.

· At least 3 years’ experience in the pharmaceuticalindustry (preferably in Drug Substance)

· Experiences across multiple site functions(including but not limited to Quality, Engineering, or Supply Chain) desirablebut not required.

· Experience in change management in a GMPenvironment.

· Experience in technical writing for GMPdocumentation and quality investigations.

· Self-motivated with excellent organizationalskills

· Excellent verbal and written communicationskills

· Proficient in Microsoft Office Tools(word/excel/PowerPoint)

· Ability to work independently and as part of ateam in a cross functional collaborative environment.

· High level of attention to detail

· Experience working with GMP DocumentationManagement Systems

· Good interpersonal skills

Qualifications:

· At minimum level 7 in a relevant Qualification.