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 Validation Specialist position. This position reports to the Lead, Equipment and Computerized System Validation and requires experience at authoring, and testing laboratory equipment and computerized systems validation projects in the pharma industry.
The primary role is to provide validation expertise to develop and coordinate deliverables to validate laboratory equipment and computerized systems for regulated use while ensuring compliance with internal procedures and industry guidelines (e.g. 21-CRF-11, GAMP, NIST, GCLP, GLP).
- Support validation laboratory equipment and computerized systems (including custom developed software);
- Write, review, finalize and coordinate the execution of software and laboratory equipment validation documentation (e.g. VP, URS, FS, RA, DS, UTCR, 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;
- Plan, collaborate, and coordinate with support team SMEs, internal stakeholders, and manufacturers to clarify validation strategies, install new equipment/software and/or ensure their modification according to business needs (e.g. repair, move, upgrade);
- Ensure equipment and software life cycle management is carried out according to business strategy and internal procedure;
- 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).
Experience and Qualifications
- Minimum of 4 years’ experience at validating laboratory equipment & computerized systems for regulated use in the pharmaceutical industry;
- Project management experience using MS project is highly desirable;
- Excellent teamwork, service oriented and organizational skills;
- Very strong English writing and communication skills;
- Ability to work methodically with precision, accuracy and quality;
- Strong working experience in regulated pharma environments;
- Proficient with office tools (e.g. Word, Excel, Outlook).
B.Sc. in Biology or Engineering