Posted on 3rd June 2019
Senior Computer Systems Validation Specialist
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. Come grow with us!
Summary of Position
The Senior Computer Systems Validation Specialist position shall provide validation support for computerized systems, software, and IT infrastructure that have been newly installed, upgraded, replaced and / or modified in a cGMP Manufacturing Facility as well as its related support areas, which may include Facilities / Engineering, Quality Assurance, Supply Chain, and Quality Control.
- Author, review and/or approve cGMP risk assessments, user requirements and functional specifications, validation plans, qualification test protocols (i.e. IQ, OQ, PQ), reports, addendums and other validation efforts as required.
- Managing and coordinating all aspects of the computer systems validation activities as they pertain to SDLC, including project planning, developing validation strategies, document development and document reviews.
- 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.
- 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.
- Perform analytical instrument validation which may include, but not limited to, computerized system validation.
- 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.
- Initiate and lead risk assessment, gap analysis, and deviation management associated with validation of lab instruments.
- Complete periodic reviews of cGMP systems, instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state.
- All other responsibilities as assigned with or without accommodation.
- Bachelor Degree required in a Science or Engineering related discipline. (Nuclear or Chemical related fields preferred.)
- 5 to 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 / maintaining instrument systems including Gamma / Alpha Spectroscopy related to Canberra / Mirion Instrumentation 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.
- Willingness and interest in learning new skills.
- Willing to travel.
- 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.
- Must be willing to wear a variety of personal protective equipment.
- May be required to sit or stand for long periods of time while performing duties.
- 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 operations.
- Some gowning may be required to enter laboratory areas.
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, veteran or disability status.