PharmaLex
Overview
This position is a fixed term contract supporting one of ECHO Consulting Group (A Cencora company) partners on site at their facility in Juncos, PR.
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
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 day. In 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 https://www.virtualfairhub.com/cencora
Employment Type Full-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 company’s 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 hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Affiliated Companies Affiliated Companies: Echo Consulting Group Inc
Seniority level Mid-Senior level
Job function Engineering and Information Technology
Industries Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at PharmaLex by 2x
Get notified about new Senior Software Quality Engineer jobs in
Juncos, Puerto Rico .
Principle Software Quality Engineer - 114 We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
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
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 day. In 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 https://www.virtualfairhub.com/cencora
Employment Type Full-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 company’s 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 hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Affiliated Companies Affiliated Companies: Echo Consulting Group Inc
Seniority level Mid-Senior level
Job function Engineering and Information Technology
Industries Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at PharmaLex by 2x
Get notified about new Senior Software Quality Engineer jobs in
Juncos, Puerto Rico .
Principle Software Quality Engineer - 114 We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr