Sr Validation Scientist

Juncos, PR
Autónomo
Tiempo completo

Hace 20 días

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!Job DetailsSummary of Role:
Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment.Responsibilities:

Able to troubleshoot systemic validation issues.
Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects.
Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity.
Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures.
Develop validation engineering policies and procedures that affect multiple organizational units.
Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.
Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise.
Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields.
Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.
Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints.
Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
Prompt and regular attendance to the workplace.
*Other functions may be assigned

Knowledge:

Advanced validation knowledge (equipment qualification, cleaning, sterilization).
Applies extensive technical validation expertise, and has full knowledge of other related disciplines.

Problem Solving:

Provide technical solutions to a wide range of difficult problems.
Solutions are imaginative, thorough, practicable, and consistent with organization objectives.

Discretion/Latitude:

Exercises considerable latitude in determining technical objectives of assignment.
Completed work is reviewed from a relatively long- term perspective, for desired results.
Supervision and guidance relate largely to overall objectives, critical issues, new concepts, and policy matters.

Impact:

Essential to the completion of broad programs and projects.
Decisions, recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization.

Leadership:

Leads efforts of group of peers directly supervises staff or project resources.
Guides the successful completion of major programs and may function in a project leadership role.
May be expected to directly supervise staff or project resources.

Liaison:

Represents the organization as the prime technical contact on contracts and projects.
Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.

Regulatory:

Understands regulatory trends in industry and able to make connection between those trends and established corporate direction.
Some direct experience with FDA or equivalent regulatory body.
Represents the organization as the technical expert to endorse the organization's validation programs and practices

Shift: Administrative shift (the staff needs to be available to work on any shift including weekends when required for on the floor executions)Location: Juncos, PREducation:Doctorate degree OR Master's degree and 3 years of directly related experience OR Bachelor's degree and 5 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experiencePreferred Qualifications:

Experience in Aseptic Process Simulation (Media Fills), Airflow Visualization Studies (Smoke Studies), Environmental Characterization/Qualification
Experience in Parenteral Manufacturing, Isolators

Skills

In-depth knowledge of validation processes and requirements.
Interacts effectively with variety of communication and working styles.
Ability to independently determine when additional internal resources are required to solve problems.
Ability to handle multiple projects at one time.
Demonstrated Skills in the following areas: schedule development, facilitation, collaboration.
Basic project management.
Completion and follow-up.
Technical expertise areas of validation engineering.
Ability to independently determine when additional external resources are required to solve problems.
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
Working knowledge of financial analysis tools.
Ability to delegate and manage the project work of others.
Demonstrated Skills in the following areas: Negotiation, persuasion and facilitation, collaboration, project cost development, conflict resolution, decision making, leadership and teambuilding, management of contractors and vendors.

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 offersWe 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, visitFull timeEqual Employment OpportunityCencora 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 . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returnedAffiliated Companies Affiliated Companies: Echo Consulting Group Inc

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