24 days old

Sr Validation Engineer

Kelly Services
Manatí, PR 00674

Accountable for the design and execution of IQ/OQ/PQ studies of process for parenteral and oral solid drug dosages products manufactured at Customer Site. Accountable for designing and executing qualification studies for sterilization/Depyrogenation/bio-decontamination equipment (autoclaves & SIP, tunnel, isolator), utilities and facilities to support their effectiveness in the manufacture of parenteral/oral solid drug dosages products. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required for the job function.

1. Conduct critical sterilization/Depyrogenation/bio-decontamination equipment (tanks, autoclaves & SIP, tunnel, isolator), utilities and facilities qualification studies (Critical utilities/systems includes Purified Water, HVAC, compressed gases) to ensure that a system functions as to routinely produce results that meet predetermined specifications.

2. Conduct temperature/relative humidity mapping qualification studies (cold boxes, freezers, and incubators) to ensure that a system functions as to routinely produce results that meet predetermined specifications.

3. Prepares operational qualification assessments to support that validated critical operating parameters are within qualified parameters for specific parenteral. Identify and evaluate equipment enhancements to support intended qualified operational ranges.

4. Hands on experience in the use/troubleshooting of validation equipment such as KAYE Validator, thermocouples, and temperature/relative humidity data loggers.

5. Supports the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications.

6. Supports process capability and statistical analysis related to equipment performance within parenteral manufacturing process

7. Serves as Subject Matter Expert for qualifications during regulatory audits (internal and external).

8. Supports the periodic review of equipment/system qualifications studies.

9. Assists and performs as the liaison person with the Information Technology Department in the implementation and qualification of upgraded equipment control systems and automation initiatives.

10. Prepares well-documented protocols for all equipment/utilities qualification exercises in compliance with corporate guidelines, procedures, FDA Regulations, and industry current practices.

11. Executes and ensures successful and timely equipment/utilities qualification activities as per established protocol in support of the manufacturing operation at the site.

12. Executes activities according to the Time and Event schedule developed by the site team.

13. Performs in process test as required, analyze qualification data, and generate conclusions based on test results and reports the results in an accurate and timely manner.

14. Performs successful and on time resolution of incidents and deviations related to equipment/utilities qualification exercises.

15. Proposes and formalizes alternatives for enhancement of site qualification program.

16. Investigates and conducts troubleshooting and root-cause analysis of unexpected trends or results during equipment/utilities qualification activities, implements accurate and timely solutions and develop and manage plans as needed.

17. Evaluates deviations with respect to their causes and corrective actions to prevent recurrence.

18. Identifies, plans, and implements quality and productivity initiatives associated to equipment/utilities qualification activities based on business needs and priorities.

19. Assures the accuracy and correctness of documentation used during equipment/utilities qualification activities.

20. Training of manufacturing and QC/QA personnel on the qualification documentation.

21. Assures compliance to corporate guidelines and site procedures governing overall operation.

22. Maintains documentation in accordance with cGMP and FDA regulations.

23. Maintains equipment/utilities qualification program in conformance with department standards and government/corporate regulations


Bachelors degree in Chemistry or Engineering.

Five (5) years of experience in a pharmaceutical industry.

Proficient technical knowledge/expertise in pharmaceutical manufacturing processes/technologies and processing equipment for parenteral manufacturing, including packaging technologies.

Proficient knowledge of equipment/utilities qualification, continuous process improvement and troubleshooting processes.

Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts, and theories in innovative ways to equipment/utilities qualification.

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

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2022-05-02 Expires: 2022-06-02

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Sr Validation Engineer

Kelly Services
Manatí, PR 00674

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