Engineer

PURPOSE AND SCOPE OF POSITION:

The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Contractor has primary responsibility to ensure that the tasks supporting validation of Manufacturing Execution Systems (MES) are documented in accordance with the relevant BMS procedures and regulations.

DUTIES AND RESPONSIBILITIES:

· Author, review and/or approve applicable CSV documentation

· Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures

· Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations

· Other related duties as assigned

Skills

MES experience Required

unicorn

Syncade.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Ability to effectively communicate with both technical and non-technical team members.

• Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.

• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.

• Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow).

• Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).

• Strong technical and problem-solving skills and the ability to work independently.

• Demonstrated success working in a high-performing, business results-driven environment.

• Understanding of computer system validation.

• Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch).

• Understanding of computer system validation (CSV).

Education and Experience:

· Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement) 4+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures

· Strong knowledge on Manufacturing Execution System (MES) validation.

· Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures

· Strong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)