PAbout 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 deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Overview:
The MS&T Process Engineer delivers a range of technical support to the Drug Substance Business: leading technical investigations within the Integrated Process Team, supporting significant projects across the site, supporting design, construction and qualification of upstream & downstream equipment (when applicable), NPI/technology transfer and commercialization. The MS&T Process Engineer ensures that MS&T team objectives are effectively achieved, consistent with the requirements to ensure compliance, safety and reliable supply to our customers, while creating an inclusive culture that energizes a Safety First, Quality Always, continuous improvement mindset.
Requirements
Primary Responsibilities:
* Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
* Design/Author/Review/Approve/Execute qualification documentation in line with the standard process.
* Leads experimental design of studies, execution, data analysis and interpretation. Authors and reviews batch documentation, regulatory and technical documentation
* Interpret trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
* Support the execution of development and PPQ batches, change control management and implementation
* Lead multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus through Lean Six Sigma methodologies.
* Lead and facilitate investigations, ensuring effective Root Cause Analysis and CAPAs. Participate in audits and inspections.
* Lead and/or support various site initiatives to improve compliance status and overall operational efficiency of the site. Serve as a key member during internal audits and external inspections/audits
* Lead and support various MS&T 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.
Qualification and Experience:
General competencies:
* Demonstrated leadership and change management skills with a continuous improvement focus.
* Proven track record of delivering high performance through development and coaching of a team.
* Evidence of continuous professional development.
* Strong collaboration to promote knowledge sharing and implementation of best practices across the site.
* Motivation to be an inspiring member of a high performing team and passion to build the future Desire to continuously learn, improve and develop.
* Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work/ upskill/coach a team environment.
Technical:
* SME in upstream/downstream processing and process control strategies. Working knowledge of analytics.
* Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment.
* Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
* Evidence of continuous professional development. Technical writing skills.
* Ability to effectively articulate understanding biologics processes, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
* Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes.
Minimum Education/Experience:
* Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification
* Experience leading technical related projects.
* Experience with upstream cell culture and/or downstream purification of biological molecules.
* Experience in preparing for and presenting in front of regulatory audits as SME.
* Experience with technology transfer, regulatory filing and commercial drug substance manufacturing of biologics is a plus.
* 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 CTD sections and/or working with external contract organization for development and/or manufacturing.
* Experience in change management, deviations and CAPAs management.