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 PropositionEmployees 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:Responsible for supporting the Engineering Department in
a GMP and Sterile Environment. Ensure that objectives are effectively achieved,
consistent with client requirements to ensure compliance, safety and reliable
supply to our customers.RequirementsRole Function:Direct and/lead deviations, out of tolerance conditions
and unexpected results, conducting failure analysis, root cause determination
and implementing corrective actions.Preparation and analysis of Engineering metrics reports
to trend for improved operational efficiencies.Format, write, deliver and review necessary documentation
in line with the standard approval process, and facilitate others to do so.
Documents will include SOP’s, SWI’s, training documents, JSA’s, PM's and change
controls.Accountable for leading investigation analysis,
identifying true root cause, identifying gaps and actions to close gaps.
Collaborate with Engineering colleagues and other departments particularly IPT,
Quality, EHS, Technical Engineering in completion of tasks.Required to comply with 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. Work collaboratively to drive a safe and compliant culture. May
be required to perform other duties as assignedSupport Audit Readiness activities The role has an element of hybrid,initially would be looking for min 4 days on
site – this could move to 3 days on site after 9 months or so. Experience, Knowledge & Skills:Technical:Effective communication and interpersonal skills to
interface effectively with all levels of colleagues in a team environmentKnowledge of regulatory/code requirements to Irish,
European and International Codes, Standards and PracticesReport, standards, policy writing skills requiredSterile filling processes and equipment experience
preferred.Proficiency in Microsoft Office and job related computer
applications required Lean Six Sigma Methodology experience desiredBusiness:Effective communication and interpersonal skills to
interface effectively with all levels of colleagues in a team environment, and
with external customersUnderstand the specific responsibilities of all departments
as they relate to one’s owndepartment, understanding the business processes ones
department supports Customer serviceSelf-motivated Flexible approachEffective time management and multi-tasking skills Proven
organizational skillsExcellent attention to detail Data analysisTraining skills Starter, finisherTrouble shooting skills Goal/results orientatedLeadership:Focus on Customers and Patients CollaborateAct with Candor and Courage Make Rapid, Disciplined
Decisions Drive ResultsBuild TalentDemonstrate Ethics and Integrity Qualifications & Education:Diploma or higher preferred, ideally in a related
discipline.Typical Minimum ExperienceWould typically have prior related work experience;
ideally in a manufacturing, preferably GMP setting#LI-AP1