MV01-022624 Senior Validation Scientist - Equipment

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Senior Validation Scientist - Equipment

Responsibiltiies:
Accountable for the design and execution of IQ/OQ/PQ studies of process for parenteral products manufactured. Accountable for designing and executing qualification studies for sterilization/Depyrogenation/bio-decontamination equipment (autoclaves & SIP, tunnel, isolator), utilities, facilities and cleaning 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. Conducts process/packaging equipment installation/operational/performance qualification studies to test their functionality for the manufacture of parenteral products.
2. Conducts 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.
3. Conducts 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.
4. Prepares operational qualification assessments to support that validated critical operating parameters are within qualified parameters for specific parenteral products. Identify and evaluate equipment enhancements to support intended qualified operational ranges.
5. Hands on experience in the use/troubleshooting of validation equipment such as KAYE Validator AVS, thermocouples and temperature/relative humidity data loggers.
6. Supports the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications.
7. Supports process capability and statistical analysis related to equipment performance within parenteral manufacturing process
8. Serves as Subject Matter Expert for qualifications during regulatory audits (internal and external).
9. Supports the periodic review of equipment/system qualifications studies.
10. 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.
11. Prepares well-documented protocols for all equipment/utilities qualification exercises in compliance with corporate guidelines, procedures, FDA Regulations and industry current practices.
12. Executes and ensures successful and timely equipment/utilities qualification activities as per established protocol in support of the manufacturing operation at the site.
13. Executes activities according to the Time and Event schedule developed by the site team.
14. 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.
15. Performs successful and on time resolution of incidents and deviations related to equipment/utilities qualification exercises.
16. Proposes and formalizes alternatives for enhancement of site qualification program.
17. 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.
18. Evaluates deviations with respect to their causes and corrective actions to prevent recurrence.
19. Identifies, plans, and implements quality and productivity initiatives associated to equipment/utilities qualification activities based on business needs and priorities.
20. Assures the accuracy and correctness of documentation used during equipment/utilities qualification activities.
21. Trains manufacturing and QC/QA personnel on the qualification documentation.
22. Assures compliance to corporate guidelines and site procedures governing overall operation.
23. Maintains documentation in accordance with cGMP and FDA regulations.
24. Maintains equipment/utilities qualification program in conformance with department standards and government/corporate regulations.

Minimum Requirements:

• Bachelor Degree in Pharmacy, Chemistry or Engineering.
• Five (5) years of experience in a pharmaceutical industry with at least three to four (3-4) years in parenteral products forms.
• Proficient technical knowledge/expertise in pharmaceutical manufacturing processes/technologies and processing equipment for oral dosage forms, 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.
• Strong project management skills.
• Proficient time management skills, planning and organization capabilities.
• Proven ability to influence and work with people at different levels and departments.
• Proven leadership & teamwork skills, self-starter, results oriented and build and maintain strong relationships with multiple groups.
• Proficient in design and execution of IQ/OQ/PQ studies of process for parenteral products manufactured. Accountable for designing and executing qualification studies for sterilization/Depyrogenation/bio-decontamination equipment (autoclaves & SIP, tunnel, isolator), utilities and facilities.
• Proficient in design and execution of Cleaning Qualification studies.
• Available to work extended hours, possibility of weekends and holidays.