Responsible for performing all aspects of software development projects for the R&D group in a cGMP regulated environment, effectively applying CRL’s methodology and enforcing project standards. Provides planning, coordination, direction and software design for the organization as well as provides compliance support for software development. Performs day-to-day operational aspects of projects. Collaborates with other team member to his/her fullest potential and works together in the most efficient manner.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
-Work with Sr. Software Project Manager, Software Project Manager and Director of R&D to help establish strategic direction and set annual goals for software development projects in support of the business.
-Contribute to the development projects from initiation to completion, including project planning, development, testing and implementation.
-Work with outside software development consultants and vendors as needed.
-Implement all software policies and procedures, including those for regulatory compliance, architecture, security, data backup and archiving, document management and disaster recovery standards.
-Ensure that development work employs proper configuration management and project tracking controls.
-Collaborate with the Quality department to ensure that proper change control procedures and documentation are in place.
-Collaborate with operations to ensure software requirements satisfy the needs of the organization.
-Minimize exposure and risk on project.
-Ensure project documents are complete, current, and stored appropriately.
-Resolve and/or escalate issues in a timely fashion.
-Participate in project review meetings.
-Lead training and / or ensure effective knowledge transfer to those responsible for training use of the new solutions such that adoption and value realization is optimized.
-Ensure adherence to pertinent regulatory requirements [FDA guidelines, cGMP 21 CFR Part 11, MHRA, GAMP5 and strict Data Integrity considerations and IQ/OQ/PQ requirements] and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
-Perform all other related duties as assigned.
Education: Bachelor’s degree (B.A./B.S.) or equivalent in software development or related discipline. Master’s degree (M.A./M.S.) is preferred.
Experience: Five or more years’ experience in software development in a combination of scientific and business domains. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Other: Strong technical knowledge of Java software development, networking, PC and MAC operating systems. Ability to program in several development environments including Windows and MAC OSX (UNIX), and in several software languages and APIs including JBoss application server, Swing, Hibernate, querying and programming facility with SQL databases (especially PostgreSQL), C, C++, Visual Basic, PHP, and HTML is preferred. Extensive scientific application development experience in a GxP regulated environment strongly preferred. Project management experience is preferred. Working knowledge of quality systems.
Equal Employment Opportunity Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet