Lead, Equipment and Computerized System Validation
Work schedulePermanent, full time
Start dateAs soon as possible
With unrivaled expertise in immunology, and operating sites in North America (East and West Coast) and Europe, Nexelis is a leading provider of assay development and advanced laboratory testing services in the infectious diseases, metabolic diseases, and oncology fields. Our versatile team of scientists, working with our advanced technology platforms, were instrumental in the development, qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines, anti-viral drugs, and immunotherapy, gene and cell therapy products.
We are currently looking for a motivated candidate with experience to fill the Lead, Equipment and Computerized System Validation position. This position reports to the Director, Automation, Maintenance & Validation and requires very strong experience at authoring, reviewing and testing laboratory equipment & computerized system validation projects in the pharma industry.
The primary role is to provide validation expertise to develop, review, approve and coordinate deliverables to release/modify/decommission computerized systems and laboratory equipment for regulated use while ensuring compliance with internal procedures and industry guidelines (e.g. 21-CRF-11, GAMP, NIST, GCLP, GLP).
- Drive the revalidation of priority lab equipment and computerized systems at the Seattle site;
- Support validation of laboratory computerized systems (including custom developed software) and equipment;
- Write, review, finalize and coordinate the execution of software and laboratory equipment validation documentation (e.g. VP, URS, FS, RA, DS, UT/CR, IQ/OQ/PQ, TM, VR) according to internal procedure and priorities;
- Write, review, finalize and coordinate the approval of support operation documentation (e.g. procedures, internal audits, periodic reviews, deviation reports, service contracts) according to internal procedure and priorities;
- Collaborate with support team to clarify lab equipment and computerized system validation strategies to ensure they are properly validated/maintained for indented use (e.g. repair, move, upgrade);
- Ensure equipment and software life cycle management is carried out according to business strategy and internal procedure.
Experience and Qualifications
- Minimum of 8 years’ experience at validating computerized systems and laboratory equipment for regulated use in the pharmaceutical industry;
- Minimum 6 years’ experience coordinating various technology implementation projects;
- Minimum 4 years’ experience leading a team of validation specialists;
- Project management experience using MS project;
- Excellent teamwork, service oriented and organizational skills;
- Very strong technical writing and communication skills;
- Extensive working experience in regulated pharma environments (GLP or GMP);
- Highly proficient with MS office tools (e.g. Word, Outlook, Excel);
- Ability to work methodically with precision, accuracy and quality.
B.Sc. in Biology or Engineering