Job DescriptionAbout PSC Biotech 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 to 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 through 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 regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Overview: A fantastic opportunity has arisen for a Downstream Bioprocess Associate.
The site will play a pivotal role in the manufacture of our biologics-based medicines, including in the area of immuno-oncology.
Our Biotech Facility will be our first-ever Large-Scale Mammalian-Based Drug Substance Facility, with the mission and ambition to manufacture breakthrough medicines from Ireland serving patients around the world.
This facility is a significant supplier of drug substances for our Immuno-Oncology treatments and will also be critical in the future supply of new biotechnology products to its global network.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
RequirementsRole Functions: Work with the manufacturing operations group, project design team, the CQV team, and the Automation/CSV reps to facilitate the development and validation of the Biotech facility manufacturing facility.
Support Equipment Design/HAZOP and Room programming reviews as per requirements.
Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., EHS metrics, Production Plan, OEE, compliance, and team training.
Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures.
Work as part of a dedicated process team where flexibility and teamwork are key requirements.
Generate SOPs/Electronic Batch Records for start-up.
Adhere to Right First-Time principles.
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 and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.
Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan.
Experience, Knowledge & Skills: General: Demonstrated successes in a team environment, such as project teams, Lean Six Sigma teams, etc.
Demonstrated problem-solving capabilities.
Knowledge of applying Lean Six Sigma and Lean methodologies in a workplace environment.
Technical: Experience in a highly regulated pharmaceutical manufacturing environment is desirable.
Start-up experience in a large-scale commercial drug substance facility is desirable but not essential.
Good understanding of Upstream/Downstream Processing and experience is an advantage.
People: Ability to interact with multiple stakeholders across numerous departments.
Excellent communication skills and the ability to work in a cross-functional collaborative environment.
Good interpersonal skills, attentiveness, and an approachable manner for interactions with inter-departmental colleagues.
High degree of problem-solving ability and adherence to scheduled timelines.
Qualification: Minimum of a Level 7 qualification in a science or engineering discipline.
A level 6 with a minimum of 3 years' experience in a GMP Manufacturing requirement shall be deemed equivalent.
Shift Pattern: 24/7, 4-Cycle shift (2 Days, 2 Nights, 4 days off)
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