Senior Specialist -Process Engineer
- Compensation
- Not disclosed
- Location
- Dublin, Ireland
- Work setup
- Hybrid
- Seniority
- Senior
- Employment
- Contract
- Experience
- 5+ years
- Category
- Industrial engineering
- Posted
Skills
Must have
- Reporting through the site manufacturing and technology head and based at the site, the Senior Specialist, Process Engineering responsibilities include, but are not limited to the following:
- Support the design, construction and qualification of upstream & downstream equipment through to technology transfer and commercialization.
- Support establishment of the commercial process and routine manufacturing by:
- Supporting experimental design, execution, data analysis and interpretation.
- Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MV
- Supporting deviation management.
- Supporting change control prioritization and implementation.
- Authoring and reviewing of batch documentation, technical reports and global regulatory submissions.
- Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
- Applying Lean Six Sigma tools by:
- Securing continuity of an appropriate LSS/CEM level of knowledge.
- Facilitating problem solving & risk assessment (FMEA) projects/meetings.
- Making problems visible and strive for continuous improvement.
- Serving as a key member during internal audits and external inspections/audits
- Lead and support various manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
- Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
Nice to have
- Experience with upstream cell culture and/or downstream purification of biological molecules. Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of bio
- Technical operations experience in the drug substance manufacture of biological molecules at commercial-scale.
- Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory C
- Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
- Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes
Full 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 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
Overview
The Senior Specialist - Engineering’s role will be
essential in ensuring efficient and effective compliant design, construction,
qualification, approval and operation of the new state-of-the-art facility
during the initial project phase. The successful candidate will take a lead on
utilising the latest innovations in technology and automation to create a
workplace of the future.
Requirements
Role:
- Reporting through the site manufacturing and technology
head and based at the site, the Senior Specialist, Process Engineering
responsibilities include, but are not limited to the following:
- Support the design, construction and qualification of
upstream & downstream equipment through to technology transfer and
commercialization.
- Support establishment of the commercial process and
routine manufacturing by:
- Supporting experimental design, execution, data analysis
and interpretation.