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.Job Purpose:This role will be part of Manufacturing Self Directed work
team/ Hub in the new state of the art single use multi-product biotech facility
in County Meath, Ireland. The organisational structure at the site will be
based on self-directed work teams where decisions will be made at the level
where the data exists.The Lead Manufacturing Biotech Associate is a leader with
strong interpersonal, communication, and collaboration skills. The Lead
Manufacturing Biotech Associate is responsible for supporting the manufacturing
process, while creating an inclusive culture that energizes a Safety First,
Quality Always, with a continuous improvement mindset.Ensure that objectives are effectively achieved, consistent
with client’s requirements to ensure compliance, safety and provide a reliable
supply to our customers.RequirementsResponsibilities:Carry out and support operations to achieve assigned duties.Deliver shift standard work for a team-based approach to
batch progression.Complete COMMIT cards to highlight ways of working within
our SDWT’s and Hubs and across our site that support our COMMIT culture.Conduct sampling/ in-process testing supporting the
manufacturing and validation processes.Document executed activities necessary to allow proper
accountability and traceability of production records, Right First Time (RFT).Author, review, and/or edit procedures and technical
documents to ensure the documents are in accordance with cGMP requirements.Provide coaching to the shift teams on the RFT approach to
documentation.Ensure that all assigned tasks related to manufacturing
documentation support is in accordance with good manufacturing practices.Initiate/ maintain housekeeping in all work areas.Identify, escalate and address compliance, environmental,
safety, and process deviations as appropriate.Support execution of safety walkdowns, audits/ inspections,
risk assessment, implementation of agreed upon actions, etc.Ensure incident investigations are fully supported with
improvement actions implemented and participate in investigations arising from
manufacturing documentation aspects as and when required.Coach and provide oversight on the shop floor to identify
potential issues before they arise.Actively participate on cross-functional manufacturing teams
to advance projects, goals and deliverables.Lead approved projects and continuous improvement
initiatives that are in alignment with the site strategies.Lead straight-through document accuracy metrics and the
development of a CI framework.Support site functional initiatives to improve compliance
status and operational efficiency of the site.Run handover boards and provide key updates to shift leads
for handover.Be escalation point of contact (POC) for troubleshooting,
supporting task execution, problem solving, CI projects and assist with the
resolution of issues/ delays.Take ownership of activities within a suite and act as a
delegate for the shift lead if they are unavailable.Ensure process equipment is maintained including
preventative maintenance, equipment troubleshooting and repairs to ensure
continuous, reliable and repeatable operation of equipment.Effectively manage and schedule equipment shutdowns.Ensure resources are available, thereby minimizing downtime.Any other duties as and when assigned by the Manager. Such
as act as a designee for Manufacturing Shift Lead as required. Educational and Experience Requirements:General Competencies:Strong collaboration and cross-functional leadership skills
to drive continuous improvement and promote knowledge sharing and
implementation of Good Manufacturing Practices.Ability to effectively coach new trainees to build their
skills so that they may become effective operations technicians and subject
matter experts.Ability to think logically and be proactive under pressure.Excellent trouble shooting and problem-solving skills to
coach and mentor the teams through complex problems solving. Technical:On-the-floor current Good Manufacturing Practice (cGMP)
manufacturing and familiarity with regulatory requirements.Proficiency with automated systems such as Manufacturing
Execution System (MES - PAS X), Systems Applications and Products (SAP), Delta
V etc.Knowledge of Lean methodologies.Familiar with all Safety, GMP, Environmental and Validation
permits, policies and procedures.Familiar with plant equipment.Training others and/ or leading hands-on or instructor-led
training.Ability to read, write and understand technical information. Minimum Education/ Experience:Bachelors Level 8 degree in science, engineering or other
technical discipline, or a Level 7 qualification in a science or engineering
discipline with a minimum of 5 years’ experience in a GMP regulated
environment.5 years experience in a regulated GMP environment.3 years experience in Biopharma industry, with direct
experience of biologics manufacture would be desirable.Proven record of accomplishments in a regulated industry
required. Other Job Requirements:This role is a site based position.This role will involve working shift, on a 24/7 basis.#LI-BR1