Validation Specialist II - De Pere, United States - Moriah Engineering

Moriah Engineering De Pere, United States

2 weeks ago

Description

Job Description

Job Description Salary:

OVERVIEW
As a Validation Specialist II you will be responsible for generating SDLC documentation and

validating/qualifying

the systems used to develop and/or manufacture products within our assigned client base.

You will ensure systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.

RESPONSIBILITES
Execute multiple large, assigned projects within our clients' needs.
Coordinate the development of new processes or troubleshoot existing ones.
Generates System Development Life Cycle documentation, including, but not limited to: Impact Assessments, User/Functional Requirements, Design/Functional Specifications, Traceability Matrix, ERES Assessments, Development Testing documents, Factory Acceptance Tests, Site Acceptance Tests, Installation and Operational Qualification Protocols, Commissioning documents, and Reports
Schedules and executes

validations/qualifications

per Standard Operating Procedures (SOPs) and regulatory guidelines.
Coordinates and communicates all testing within company resources and affected functional groups and evaluates test results.

Executes equipment, facility, utility, computer system, and Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.

Participates and presents data in Customer, Corporation, and Internal audits.
Thorough understanding of risk based validation for computerized systems, industry standards and best practices for computer system validation.
Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA)

Apply validation knowledge for

manufacturing/packaging/utilities

equipment in the to

pharmaceutical/medical

device/ food and beverage industries.
Perform all necessary engineering analysis and submit recommendations, as required.
Create project documentation and procedures (SOP) to meet with customer requirements.
Create acceptance criteria and conduct acceptance tests, if applicable.
Manage the deliverables to agreed schedule and scope of work.

Maintain excellent communications with upper management and colleagues of other functional areas to assure consistency with customer policies, procedures, and processes.

Participate in staff meetings, as requested, and provide periodical project status reports.
Any other duty assigned by supervisor, related to project, company or client needs.

QUALIFICATIONS
BS/BA degree in science, engineering, manufacturing technology or closely related field is required.
Minimum of 3

years of relevant experience in validation is preferred.
Excellent attention to detail and working knowledge of FDA

Regulations/Guidance

or Good Manufacturing Practices is required.
Technical knowledge and experience with validation / qualification processes, equipment, utilities, facilities and/or computer systems is required.
Must be proactive, have experience with high performance teams, strong interpersonal.
Must be able to interact with varying levels within the company and customers.

Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.

Project management basic concepts:
timeline follow up, schedule reviews, predecessor.
People skills for interdisciplinary share.
Self-driven and schedule oriented.
Ability to evaluate compliance issues.
Strong conflict resolution skills.

PREFERRED
QUALIFICATIONS
Validation experience as related to sterile products, pharmaceutical products and medical devices is preferred.
Interpretation of electrical drawings, P&ID, and network diagrams preferred.
Validation certification preferred.
HMI and PLC basic knowledge, preferred.

PHYSICAL/MENTAL REQUIREMENTS

Must be able to lift and carry light loads as necessary in conducting testing.
May involve standing for long periods of time.
May require extended working shifts.

Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements.

Must be able to climb ladders/steps.
Must be able to lift items of 25lbs.

Moriah Engineering Solutions is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, ancestry, national origin, age, gender identity, gender expression, sex/gender, marital status, sexual orientation, physical or mental disability, medical condition, military/veteran status, basis of genetic information, or any other group protected by law .

#J-18808-Ljbffr

Validation Specialist

2 weeks ago

Validation & Engineering Group Inc. De Pere, United States

Job Description · Job Description · 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, Compute ...
Validation Specialist

2 weeks ago

Validation & Engineering Group Inc. De Pere, United States

Job Description Job Description 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, Engine ...
Process Validation Specialist

3 weeks ago

Validation & Engineering Group Inc. De Pere, United States

Job Description · Job Description · 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, Compute ...
Validation Specialist III

3 weeks ago

Moriah Engineering De Pere, United States

Job Description · Job Description Salary: · OVERVIEW · As a Validation Specialist III you will be responsible for generating SDLC documentation and · validating/qualifying · the systems used to develop and/or manufacture products within our assigned client base. You will ensur ...
Validation Specialist II

3 weeks ago

Moriah Engineering De Pere, United States

Job Description Job Description Salary:OVERVIEWAs a Validation Specialist II you will be responsible for generating SDLC documentation and validating/qualifying the systems used to develop and/or manufacture products within our assigned client base. You will ensure systems are ru ...
Validation Specialist III

3 weeks ago

Moriah Engineering De Pere, United States

Job Description Job Description Salary:OVERVIEWAs a Validation Specialist III you will be responsible for generating SDLC documentation and validating/qualifying the systems used to develop and/or manufacture products within our assigned client base. You will ensure systems are r ...
Youth and Family Specialist

3 weeks ago

Family Services of Northeast Wisconsin Inc. Green Bay, United States Full time

Are you ready to work for an employer who cares about your well-being? Family Services cares about their team and in addition to their excellent benefit package, they are now offering a staff sabbatical program. Being the helper is hard work and Family Services doesn't want you t ...
Customer Service Representative

2 weeks ago

DES Group Green Bay, United States

$$ WEEKLY PAY $$ · NO EXPERIENCE REQUIRED · HELP WANTED · We are looking for a customer-oriented service representative. A customer service representative, or CSR, will act as a liaison, provide product/services information and resolve any emerging problems that our customer acco ...
Customer Service Representative

5 days ago

DES Group Green Bay, United States

Customer Service Representatives · $$ WEEKLY PAY $$ · NO EXPERIENCE REQUIRED · HELP WANTED · We are looking for a customer-oriented service representative. A customer service representative, or CSR, will act as a liaison, provide product/services information and resolve any emerg ...
Fiscal Enrollment Specialist

1 week ago

AssuranceSD Green Bay, United States

About the Company: · LKiChoice is part of the AssuranceSD Family. We are a mission-driven organization providing administrative services that enable individuals to take ownership of their personal care services, ensuring that they receive quality and comprehensive care with mínim ...
Erosion Control Specialist

1 week ago

City of Green Bay, WI Green Bay, United States

**General Description**: · Are you dedicated to environmental protection and looking to make a meaningful impact in the community? We are seeking a skilled Erosion Control Specialist to take on an important role in implementing and enforcing our soil erosion and sediment control ...
Clinical Laboratory Technician Ii

2 weeks ago

Bassett Medical Cooperstown, United States

Overview: · Are you looking to make a difference by improving the health of our patients? Here you will find an innovative culture that is patient-focused and dedicated to making a difference. We are committed to helping the population we serve, and our communities, achieve optim ...
Specialty Floor Care Technician

2 weeks ago

Jack's Maintenance Service Appleton, United States

Jack's Maintenance Service is currently looking to hire hard working and driven **Floor Care Specialist Technician** with a passion to exceed and grow within our Elite company. We are a janitorial and maintenance company specializing in commercial cleaning. We do what it takes to ...
Epoxy Flooring Specialist

2 weeks ago

Protective Coating Specialists Appleton, United States

**EPOXY FLOORING SPECIALIST** · **Step into Success. Join Our Epoxy Flooring Team.** · **What's In It for You** · At Protective Coating Specialists (PCS), we strive to reach two goals every day - creating satisfied customers by installing the highest quality epoxy floors in the i ...
Business Analyst

2 weeks ago

UnitedHealth Group Cooperstown, United States

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel ...
Database Specialist

3 weeks ago

S3 Connections Pvt Ltd Appleton, United States

**Job Title: Database Architect** · **Department: Information Technology** · **Duration: 6 months Contract with the possibility of extension or converted to full-time.** · **Location : Appleton WI (Relocation is also fine)** · **(Only for US Citizen and Green Card Holders)** · ** ...
CQV PM

3 weeks ago

Validation & Engineering Group Inc. De Pere, United States

Job Description Job Description 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, Engine ...
CQV PM

3 weeks ago

Validation & Engineering Group Inc. De Pere, United States

Job Description · Job Description · 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, Compute ...
General Labor Lawn Care Specialist

1 week ago

Naturescape De Pere, United States

Naturescape of Green Bay, WI is seeking to hire a Lawn Care Specialist to provide our customers with outstanding services for their residential and commercial properties. Are you looking for a career in lawn and landscape care with a stable,family-owned business ? Would you like ...
Unemployment Benefit Specialist

2 weeks ago

State of Wisconsin Appleton, United States

**Introduction**: · The Adjudication Lead Worker will work in the Unemployment Insurance (UI) Division of the Department of Workforce Development (DWD). This position will work a blend of remote and in-office work at our Appleton Benefits Center. · **Position Summary**: · - Provi ...