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curium jobs

Posted on 2nd September 2018

Senior Quality Testing Engineer – New Products

United States
Quality
Permanent
1201

About Curium:

Curium was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC.  Curium is a world-class nuclear medicine solutions provider with over 100 years of combined industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service.

Our diverse group of industry experts is unified under one strong and singular focus – to develop, manufacture and supply SPECT, PET and therapeutic radiopharmaceuticals to customers around the globe.  In fact, we have over 6,000 customers in over 70 countries world-wide.

At Curium, every single dose counts in helping doctors and patients diagnose and treat disease.  That means every single employee counts toward meeting this unified objective to help each patient live “Life Forward”.  We have an amazing team that lives by our core values every single day – integrity, commitment and collaboration.  Our North American headquarters is in Maryland Heights, MO.  Come grow with us!

Scope of Position: 

Primary duties of the position are focused around non-laboratory support of the QC functions for new product support group.  It generally include, but not limited to, data analysis, data trending, project and testing coordination, product and material specification management, inspection support, document revisions, initiating/completing quality systems, method/equipment validation and method projects activities.

Specific QC Focus Areas:

  • Technical Services: Area is focused on data analysis, data trending, project and testing coordination, product specification management, LIMS interface, CoA generation, (including interaction with the IT systems such as LIMS that enables electronic management of this activity), and inspection support.
  • Stability: Area is focused on data analysis and trending of stability data, data reporting, coordination and planning of stability studies, involvement on quality events requiring stability input. Contribute to the writing of the stability sections of regulatory filings.
  • Technical Support: Area is focused on various technical projects in support of the GMP laboratories, such as automation support, method projects activities (ex. method transfer and validation support activities, method remediation and troubleshooting, method monitoring), critical reagents and reference standard programs and global technical oversight program.
  • Investigators/Quality Systems Support: Area is focused on providing non-execution based SME input on quality events and investigations that happen throughout the QC department as well as serving as key QC representatives on cross-functional teams.
  • Raw Materials: Area is focused on various projects in support of the Raw Materials department. Support includes (but not limited to) material specification creation/revision, document creation/revisions, initiating/completing quality systems, method/equipment validation and implementing operational excellence initiatives

Essential Functions:

  • Act as validation representative for instruments and Subject Matter Expert for Tech Transfers.
  • Partner with Laboratories end-users, System Administrators and the Quality Department on implementation of new instruments.
  • Upgrade current Laboratory instrumentation as needed as part of capital forecasts.
  • Perform analytical instrument validation which may include, but not limited to, computerized system validation.
  • Perform Laboratory system installation and decommissioning as required.
  • Provide end-user support for all Quality Laboratory groups as well as maintains compliance to global and site internal policies and procedures.
  • Assist the system owner with evaluating and recommending the appropriate user roles, writing instrument operation instructions, amongst other tasks.
  • Review and approve validation deliverables created by others for adherence to site validation SOPs.
  • Initiate/Review and lead change control for implementation of new instruments or changes to existing analytical instrumentation and associated instrument control software.
  • Author, review and/or approve cGMP risk assessments, user requirements & functional specifications, validation plans, qualification test protocols (i.e. IQ, OQ, PQ), reports, addendums and other validation efforts as required.
  • Evaluate and advise the system owner with recommendations for appropriate user roles and privileges for data integrity, writing instrument operation instructions and preventive maintenance plans.
  • Ensure adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines.
  • Author protocol to challenge the main aspects of regulatory requirements during validation to demonstrate adherence. For systems found unable to fully comply, develop solutions with core stake holders to mitigate the gaps.
  • Initiate and lead risk assessment, gap analysis, and deviation management associated with validation of lab instruments.
  • Complete periodic reviews of instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument.
  • All other responsibilities as assigned with or without accommodation.

Requirements:

  • Bachelor’s degree required in a science or engineering related discipline. (Nuclear or Chemical related fields preferred.)
  • 5-8 years of experience in the laboratory instrument validation field including those with computerized systems attached in a cGMP environment (required).
  • 5-8 years of experience in the pharmaceutical industry or relevant business experience within Quality Control or Validation cGMP Compliance.
  • Experience operating instrument systems including Gamma/Alpha Spectroscopy related to Canberra/Mirrion Instrumentation. (Desirable, not required)
  • Nuclear medicine industry experience desires, not preferred.
  • Demonstrated attention to detail.
  • Good oral and written communication skills.
  • Must be able to work independently as well as part of a group environment as required.
  • Proficiency with core computer software/systems (Word, Excel, Project, SharePoint, etc.).
  • Demonstrated ability to work in a team environment and manage workload to meet deadlines.
  • Ability to follow instructions in written, oral, diagram, or schedule form.
  • Good and clear communication skills.
  • Willing, able and wanting to learn new skills.

Working Conditions:

  • Standard office environment, coupled with approximately 40% time in radiopharmaceutical manufacturing and laboratory environments.
  • Must be willing to wear a variety of personal protective equipment.
  • Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
  • Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
  • Must possess good hand-eye coordination.
  • May be required to work weekends and holidays to support projects and operations.
  • Some gowning may be required to enter laboratory areas.
  • Some travel may be expected; although not routine.
  • The following physical abilities are required in order to fulfill the job duties:
    • Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
    • Ability to work around chemicals (if working around the laboratories)
    • Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer:

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality.  All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin and veteran or disability status.

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