Downstream Bioprocess Associate

• Industry Pharma/Biotech/Clinical Research
• Work Experience 1-3 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 points 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.

Requirements

Role Functions: · Work with the manufacturing operations group,project design team, the CQV team, the Automation/CSV reps to facilitate thedevelopment and validation of the Biotech facility manufacturing facility. · Support Equipment Design/ HAZOP and Roomprogramming reviews as per requirements. · Support Operations team to consistently deliveron specific area Key Performance Indicators (KPIs), e.g. EHS metrics,Production Plan, OEE, compliance and team training. · Execute commercial manufacturing processesaccording to established work instructions and Standard Operating Procedures. · Work as part of a dedicated process team whereflexibility and teamwork are a key requirement. · Generate SOPS/Electronic Batch Records forstart-up. · Adhere to Right First-Time principals. · Provide assistance and/or support maintenance,engineering, quality or other colleagues as requested. · Escalate issues as appropriate to Process Lead · Maintain a high level of personal expertise andworking knowledge of all aspects of the manufacturing process and processequipment through continuous training and development. · Liaise with other groups and individuals toensure planning of tasks is effective and linked into the manufacturing processplan. Experience, Knowledge & Skills: General: · Demonstrated successes in a team environment,such as project teams, Lean Six Sigma team, etc. · Demonstrated problem solving capabilities. · Knowledge of applying Lean Six Sigma and Leanmethodologies in a workplace environment Technical: · Experience in a highly regulated pharmaceuticalmanufacturing environment is desirable. · Start-up experience in a large-scale commercialdrug substance facility desirable but not essential. · Good understanding of Upstream/DownstreamProcessing and experience an advantage. People: · Ability to interact with multiple stakeholdersacross numerous departments. · Excellent communication skills and the abilityto work in a cross functional collaborative environment. · Good interpersonal skills, attentiveness, and anapproachable manner for interactions with inter departmental colleagues. · High degree of problem-solving ability andadherence to scheduled timelines. Qualifications & Education: · Minimum of a Level 7 qualification in a scienceor engineering discipline. · A level 6 with a minimum of 3 years’ experiencein a GMP Manufacturing requirement shall be deemed equivalent. #J-18808-Ljbffr