DYPROCS is searching a Validation Engineers for a USA based employer to join the company as a full-time permanent employee and relocate at the employer's location to the U.S.A.
The ideal candidate will be
responsible for design or plan protocols for equipment or processes to produce
products meeting internal and external purity, safety, and quality
requirements. This position requires
clear communication internally and externally, strong organizational skills,
resiliency, and a solution focused mindset!
Responsibilities:
·
Develop and
execute validation protocols for equipment, processes, and software in compliance
with industry standards and regulatory requirements (e.g., FDA, ISO).
·
Create and
maintain validation documentation, including IQ/OQ/PQ protocols, summary
reports, and change control documentation.
·
Conduct
risk assessments to identify potential validation issues and implement
corrective actions.
·
Collaborate
with design and manufacturing teams to ensure validation requirements are
integrated throughout the product lifecycle.
·
Perform
periodic reviews and re-validation of processes and systems to ensure ongoing
compliance.
·
Support
regulatory audits and inspections by providing validation documentation and
insights.
·
Stay
up-to-date with industry trends and changes in regulations related to
validation.
Proficiency &
Skills:
·
Must have 3+ years of work experience in validation engineering or related field.
·
Must have extensive experience and knowledge
specifically in validation methodologies and tools.
·
Strong
knowledge of regulatory standards and guidelines (e.g., FDA, ISO, GxP).
·
Experience
with automated validation tools and software.
·
Certification
in validation (e.g., V&V certification) is a plus.
·
Project
management experience is a plus.
·
Engineering and Technology - Knowledge of the
practical application of engineering science and technology. This includes
applying principles, techniques, procedures, and equipment to the design and
production of various goods and services.
·
Production and Processing - Knowledge of raw
materials, production processes, quality control, costs, and other techniques
for maximizing the effective manufacture and distribution of goods.
·
Customer and Personal Service - Knowledge of
principles and processes for providing customer and personal services. This
includes customer needs assessment, meeting quality standards for services, and
evaluation of customer satisfaction.
·
Mathematics - Knowledge of arithmetic,
algebra, geometry, calculus, statistics, and their applications.
·
Design - Knowledge of design techniques,
tools, and principles involved in production of precision technical plans,
blueprints, drawings, and models.
·
Mechanical - Knowledge of machines and tools,
including their designs, uses, repair, and maintenance.
·
Education and Training - Knowledge of
principles and methods for curriculum and training design, teaching and
instruction for individuals and groups, and the measurement of training
effects.
·
Administration and Management - Knowledge of
business and management principles involved in strategic planning, resource
allocation, human resources modeling, leadership technique, production methods,
and coordination of people and resources.
·
Computers and Electronics - Knowledge of
circuit boards, processors, chips, electronic equipment, and computer hardware
and software, including applications and programming.
·
Strong
leadership, communication, and interpersonal skills, with the ability to
inspire and motivate a diverse team.
·
Soft skills required - strong drive,
persistence, consistency, organization, time management, written and verbal communication.
·
Flexible mindset focused on delivering
quality deliverables on tight deadlines.
·
Excellent
analytical and problem-solving abilities, with a proactive approach to
overcoming challenges.
·
Ability to get up to speed quickly on complex
issues; desire to work in a fast-paced, rapidly evolving environment.
·
Capable self-starter with a drive to get all
types of work done and high attention to detail.
Education:
·
Bachelor’s
degree in Engineering, Life Sciences, or related field.
Salary:
·
Will be determined based on the experience
& knowledge
Must To:
·
Selected candidate must relocate to U.S.A
after completing all U.S.A visa requirements
·
Selected candidate must perform day to day
job duties physically.
·
Selected candidate will be given all benefits
per the employer’s policy