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6 days old

Sr Validation Scientist

Kelly Services
Juncos, PR 00777
**Sr Validation Scientist**


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.


FUNCTIONS

- 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.



Knowledge:

- Advanced validation knowledge (equipment qualification, cleaning, sterilization).

- Applies extensive technical validation expertise, and has full knowledge of other related disciplines.


EDUCATION/LICENSES

- 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 experience.

* **Preferred in Sciences and Engineering**


COMPETENCIES/SKILLS

1) Experience working with commissioning and qualification of drug substance equipment such as tanks, bioreactors, computerized systems and analytical equipment, facilities, and utilities

2) Must know how to read a P and ID drawing

3) Must have an understanding of what is the C and Q process and the person must be familiar with C and Q plans, systems URS, Risk Assessments, and vendors documentation.

4) Must know how to elaborate, handling and execute a testing protocol including the resolution of deviations

5) Must know how to handle a GMP document

6) Must be prepared to interact with system vendors during preparatory C and Q activities and during C and Q activities

7) Must be able to participate when a problem resolution requires C and Q team members provide guidance


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-06-20 Expires: 2022-07-21

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Sr Validation Scientist

Kelly Services
Juncos, PR 00777

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