Job Details

Requisition Number 19-0396
Post Date 12/13/2019
Title Sr. Validation Engineer
City Orangeburg
State NY
Description Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world.

We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

The Senior Validation Engineer is responsible for all aspects Process Validation, Equipment Validation and Cleaning Validation used in the development and production of medical device / pharma products. This is a hands-on position which to develop and execute validation life cycle activities according to necessary specifications and operating ranges to ensure the production of quality products. This person will also take a leadership role in engineering functions such as specifying and validating new equipment, process and materials, technical services, identifying and implementing process/product improvements. This person will support validation life cycle activities and lead process, equipment and cleaning validation projects.


ESSENTIAL FUNCTIONS AND BASIC DUTIES

1. Conduct validation or qualification studies of new or existing processes, equipment, systems or software in accordance with internal protocols or external standards.
2. Develop validation master plans, validation protocols, summary reports, deviations, process flow diagrams, test cases, and standard operating procedures/work instructions as applicable.
3. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, and other types of production.
4. Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
5. Perform DOEs and statistical analysis and support process improvements projects.
6. Lead periodic review of equipment and critical utilities for the entire site.
7. Lead cleaning validation annual monitoring projects.
8. Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
9. Develops manufacturing processes by designing and modifying equipment for fabricating, building, assembling, and installing components.
10. Provide support to R&D, manufacturing, marketing, and customer service; interface with customers and suppliers
11. Using six sigma principals, identify key process parameters and develop monitoring tools to enable cost reduction efforts
12. Manage projects in a matrix organization as a team leader, whose duty encompasses the full scope of the project
13. Drive capacity improvements by identifying and executing continuous improvement projects
14. Mentor and coach team engineers in developing new products and technologies
15. Support design and process FEMA’s
16. Author and execute validation protocols and summary reports for equipment qualifications, process and packaging validation, and cleaning validation processes to ensure regulatory agencies compliance.
17. Lead technical training efforts to corporate and plant personnel regarding the fundamentals of validation and the use of Design of Experiment and Factory Acceptance Testing.
18. Participate as Subject Matter Expert (SME) in the New Product Development Process.
19. Support validation life cycle activities by commissioning, continuous process monitoring, change controls, SOP generation, and revalidation activities.
20. Maintain Regulatory and Quality compliance, and follow PDI safety, health and environmental policies and procedures.
21. Perform other duties as assigned or as business needs.



PERFORMANCE MEASUREMENTS
1. Successful and timely completion of engineering and validation projects
2. Successful audit outcomes by internal and external auditors and regulatory agencies
3. Efforts Achieve or exceed cost savings targets by supporting Continuous Improvement

Requirements QUALIFICATIONS

EDUCATION/CERTIFICATION: Bachelor’s Degree in Engineering discipline. Pharmaceutical, Mechanical, Electrical, or Automation Engineering preferred.
Candidates with M.S. or B.S. with significant additional relevant experience in manufacturing science and technology can be considered.

REQUIRED KNOWLEDGE:
-- Thorough knowledge of FDA Guidance for Industry. Process Validation: General Principles and Practices
-Thorough knowledge of good manufacturing and documentation Practices.
-Knowledge of FDA regulatory guidance, ICH guidelines and 21 CFR Parts 210, 211, and 820.
-Thorough understanding of drug product manufacturing/packaging, equipment design and qualification requirements and equipment cleaning procedures and cleaning validation requirements.
-Thorough understanding of electro-mechanical systems with an ability to diagnose and eliminate in-efficiencies
-Good working knowledge of manufacturing methods, and an ability to effectively persuade people of all different levels within the organization
-Thorough understanding of validation life cycle (e.g. process validation, cleaning validation, equipment and facilities qualification)
- Solid understanding of computer programming and software development
-Familiar with the design controls, FDA and ISO regulations (cosmetics, drug, and medical device), and GMP practices
-Relies heavily on experience and judgment to plan and accomplish goals

EXPERIENCE REQUIRED:
7 or more years of experience in pharmaceutical Industry, FDA or ISO regulated facilities in validation engineering or related technical capacity; 4 or more years of medical device experience, wet wipes manufacturing/ packaging validation/engineering experience.

SKILLS/ABILITIES:
-Experience with lean six-sigma manufacturing and continuous improvement programs.
-Ability to perform statistical analysis, identify CPPs and CQAs and make scientific rationale/judgement.
-Excellent verbal and written communication skills required.
-Skilled in technical project management, problem solving and team building discipline.
-Ability to troubleshoot equipment problems and perform complex system tests
-Excellent interpersonal skills, social skills and collaborative sills
-Proficient in Microsoft Word, Excel, PowerPoint, Mini-Tab (or equivalent)
-Exhibits ability to increase technical knowledge and apply new skills
-Self-motivated with the ability to work independently with minimum supervision.
-Flexible and adaptable in terms of working with a diverse team.


#LI-PDI
#LI-CS1


WORKING CONDITIONS

NONE: No hazardous or significantly unpleasant conditions.

INTENT AND FUNCTION OF JOB DESCRIPTIONS

Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions. Well-constructed job descriptions are an integral part of any effective compensation system.

All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate.

In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.

Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.

Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products.
  • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
  • Please view Equal Employment Opportunity Posters provided by OFCCP here.
  • The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
  • Please refer to the Company’s Substance Abuse Policy which protects the safety and well-being of all associates and potential associates.
Apply Online
Send This Job to a Friend