Summary of Role:
ypically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education (typically University).

Responsibilities:

• Responsibilities may include the following and other duties may be assigned. Develops modifies applies and maintains standards for software systems quality operating methods processes and procedures.
• Conducts evaluation of software systems activities including requirements design development documentation integration test verification and validation.
• Defines appropriate measures to ensure product quality.
• Develops overall operating criteria to ensure implementation of the software quality program according to project process and contract requirements and objectives.
• Ensures that projects and process control documentation are compliant with requirements objectives and/or contracts.
• Reviews software systems design change specifications and plans against contractual and/or process requirements. Reviews include applicable specifications materials tools techniques and methodologies.
• Provides or directs verification and validation of software system requirements traceability and testability.

Shift: 1st and 2nd

Location: Juncos PR

Education: Engineering degree: Mechanical Electrical or Computer/Software preferred (not Science) or Programming

Preferred Qualifications:

• Experience with Risk management documentation: pFMEAs
• Basic knowledge in PLC general programming Source Code Review
• Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing)
• Engineering degree: Mechanical Electrical or Computer preferred
• Perform and/or review process validation (not cleaning processes) and equipment documents: URS FAT IQ OQ PQ TMV (not laboratory)
• Knowledge in Medical Devices regulations
• Knowledge in GAMP
• CAPA/ Investigations/ Root Cause Analyses/Technical Writing
  

Skills:

• Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions.
• Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area.
• Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties .
• Makes improvements of processes systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.
• Communication and Influence: Communicates with senior internal and external customers and vendors.
• Exchange information of facts statuses ideas and issues to achieve objective and influence decisionmaking.
• Leadership and Talent Management: May provide guidance coaching and training to other employees within job area. May manage projects requiring delegation of work and review of others work product .
• Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience.
• May have practical knowledge of project management. Requires a University Degree and minimum of 5 years of relevant experience or advanced degree with a minimum of 2 years relevant experience

This position is for a fixed term contract supporting one of ECHO Consulting Group (A Cencora company) partners on site at their facility.

What Cencora offers

We provide compensation benefits and resources that enable a highly inclusive culture and support our team members ability to live with purpose every addition to traditional offerings like medical dental and vision care we also provide a comprehensive suite of benefits that focus on the physical emotional financial and social aspects of wellness. This encompasses support for working families which may include backup dependent care adoption assistance infertility coverage family building support behavioral health solutions paid parental leave and paid caregiver leave. To encourage your personal growth we also offer a variety of training programs professional development resources and opportunities to participate in mentorship programs employee resource groups volunteer activities and much more. For details visit time

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law.

The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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