Job Description We are looking for a Manufacturing Technician at our site Westport in the mulitdose department.
( Weekend shift role 39 hours)
Responsibilities Carry out daily tasks as assigned by the Production Manager according to GMP and the quality system.
Active involvement and management of batch related CAPA's as they arise in the business unit taking them from the initial review state through RCA, approval, batch disposition and delivery of corrective and preventive actions, liaising closely with the relevant Departments and QA Lead to ensure thorough investigation is completed and timely resolution and closure is met.
Accurately completing documentation in a timely manner, accurately and legibly.
Responsible for maintaining monitoring grade A conditions inside isolator, including end of batch EM and utilizing the FMS system for data collection and completing glove testing for integrity of RAB units.
Adhering to all company standards in safety, housekeeping and quality, notifying management of any discrepancies.
Competent in surface sanitization and use of qualified Disinfectants/Detergents/Biocide cleans, competent in both SIP sterilization bespoke autoclave counter pressure training.
Manage requirements in order to deliver the KPIs as they relate to the Product Flow function with a specific emphasis on the 32 day release cycle Adhering to all company standards in safety, housekeeping and quality, notifying management of any discrepancies.
Follow gowning procedures on entry to areas and donning additional garbing for specific tasks within the compounding area.
Adhere to and support all EHS E standards, procedures, and policies.
Qualifications 2-3 Years working in a manufacturing environment, preferably Aseptic/Sterile Manufacturing.
Experience working in a cleanroom environment.
Third Level qualification in science or engineering discipline is an advantage but not essential.
Understanding of the requirements to work in a regulated GMP industry Ability to build strong relationships and work within cross-functional teams.
Adaptability to work in a fast, dynamic environment whilst adjusting readily to meet unexpected constraints.
Drive, high energy, maturity, and ability to work under pressure, deliver results, and overcome obstacles.
Team player who can collaborate with others to achieve organizational targets and goals.
Knowledge of biologics operations an advantage Excellent communication skills Ability to use sound judgment to make effective decisions within appropriate timeframes Proven to be self-directed, self-motivated and ability to prioritize competing priorities Excellent technical writing skills is a requirement for this role and previous experience on GTW i.e. opening RCC's / LIRs / CAPA's is preferrable in order to be successful within this role Ability to build strong relationships and work within cross-functional teams.
Adaptability to work in a fast, dynamic environment whilst adjusting readily to meet unexpected constraints.
Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
Equal Opportunity Employer/Veterans/Disabled.
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