Validation Engineer Temporary

JOB TITLE: Validation Engineer
JOB SUMMARY Responsible for supporting, revising and overseeing the execution of, and validation procedures/protocols to ensure that there is sufficient documentation to support the regulatory agency validation requirements, customer expectations, internal company standards, and current industry practices.
ESSENTIAL DUTIES
• Lead validation projects related to authoring and executing specifications and validation documentation according to the Validation Life Cycle. (URS, FRS, DS, IQ, OQ, PQ), and reports.
• Support risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Validation Plan.
• Develops solutions to problems that are unusual and complex that affect diverse functional areas of the company.
• Bring together multiple concepts across job areas to define a new direction or a significant advance to products and services.
• Interprets, executes and recommends modifications to operating policies on a multifunctional basis.
• Reviews, implements and enforces related SOPs.
• Primary lead on validation efforts and manages the coordination of intra and inter-company projects.
• Enforces and influences internally and externally on matters pertaining to policies, plans, projects and objectives.
OTHER DUTIES AND RESPONSIBILITIES
• Manages validation projects and priorities by leading and mentoring team members.
MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor’s degree in Business, Engineering or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Experience
Minimum 3 years’ experience in validation process.
Skills
• Priority setting and ability to manage own time to be able to work on multiple projects simultaneously.
• In-depth knowledge and experience of medical device or pharmaceutical industry standards and requirements.
• In-depth knowledge of current industry expectations of validation requirements for process validation.
• Knowledge of all current cGMP/ISO requirements in the US and globally.
• Ability to pursue solutions and make decisions with a sense of urgency.
• Requires flexibility to adapt to and a willingness to learn new technologies.
• Ability to manage team members to deliver on time and on-budget results to customers.
▪ In-depth knowledge of documentation standards and validation processes and protocols.
• Ability to determine, present, and defend project requirements and status in a professional manner
Job Description
US FLSA: Exempt JOB CODE:ENG 0004 DATE MODIFIED: 15/oct/2021
JOB BAND: 9
The above statements are intended to describe the general nature of level of work being performed by people assigned to this classification. They
are not to be construed as an exhaustive list of all responsibilities duties, and skills required of associates so classified. All associates may be
required to perform duties outside of their normal responsibilities.
Page 2 of 2
• Knowledge of GMP and CRF part 11 for validation and development of life cycle.
• Knowledge of validation testing
• Demonstrated ability to communicate effectively both verbally and in writing.
-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.
PHYSICAL REQUIREMENTS Typical Office Environment requirements include reading, speaking, hearing, close vision, walking, bending and sitting. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional Physical Requirements
• Must be able to work non-standard hours and travel as business requirements.

JOB TITLE: Validation Engineer
JOB SUMMARY Responsible for supporting, revising and overseeing the execution of, and validation procedures/protocols to ensure that there is sufficient documentation to support the regulatory agency validation requirements, customer expectations, internal company standards, and current industry practices.
ESSENTIAL DUTIES
• Lead validation projects related to authoring and executing specifications and validation documentation according to the Validation Life Cycle. (URS, FRS, DS, IQ, OQ, PQ), and reports.
• Support risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Validation Plan.
• Develops solutions to problems that are unusual and complex that affect diverse functional areas of the company.
• Bring together multiple concepts across job areas to define a new direction or a significant advance to products and services.
• Interprets, executes and recommends modifications to operating policies on a multifunctional basis.
• Reviews, implements and enforces related SOPs.
• Primary lead on validation efforts and manages the coordination of intra and inter-company projects.
• Enforces and influences internally and externally on matters pertaining to policies, plans, projects and objectives.
OTHER DUTIES AND RESPONSIBILITIES
• Manages validation projects and priorities by leading and mentoring team members.
MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor’s degree in Business, Engineering or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Experience
Minimum 3 years’ experience in validation process.
Skills
• Priority setting and ability to manage own time to be able to work on multiple projects simultaneously.
• In-depth knowledge and experience of medical device or pharmaceutical industry standards and requirements.
• In-depth knowledge of current industry expectations of validation requirements for process validation.
• Knowledge of all current cGMP/ISO requirements in the US and globally.
• Ability to pursue solutions and make decisions with a sense of urgency.
• Requires flexibility to adapt to and a willingness to learn new technologies.
• Ability to manage team members to deliver on time and on-budget results to customers.
▪ In-depth knowledge of documentation standards and validation processes and protocols.
• Ability to determine, present, and defend project requirements and status in a professional manner
Job Description
US FLSA: Exempt JOB CODE:ENG 0004 DATE MODIFIED: 15/oct/2021
JOB BAND: 9
The above statements are intended to describe the general nature of level of work being performed by people assigned to this classification. They
are not to be construed as an exhaustive list of all responsibilities duties, and skills required of associates so classified. All associates may be
required to perform duties outside of their normal responsibilities.
Page 2 of 2
• Knowledge of GMP and CRF part 11 for validation and development of life cycle.
• Knowledge of validation testing
• Demonstrated ability to communicate effectively both verbally and in writing.
-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.
PHYSICAL REQUIREMENTS Typical Office Environment requirements include reading, speaking, hearing, close vision, walking, bending and sitting. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional Physical Requirements
• Must be able to work non-standard hours and travel as business requirements.

JOB TITLE: Validation Engineer
JOB SUMMARY Responsible for supporting, revising and overseeing the execution of, and validation procedures/protocols to ensure that there is sufficient documentation to support the regulatory agency validation requirements, customer expectations, internal company standards, and current industry practices.
ESSENTIAL DUTIES
• Lead validation projects related to authoring and executing specifications and validation documentation according to the Validation Life Cycle. (URS, FRS, DS, IQ, OQ, PQ), and reports.
• Support risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Validation Plan.
• Develops solutions to problems that are unusual and complex that affect diverse functional areas of the company.
• Bring together multiple concepts across job areas to define a new direction or a significant advance to products and services.
• Interprets, executes and recommends modifications to operating policies on a multifunctional basis.
• Reviews, implements and enforces related SOPs.
• Primary lead on validation efforts and manages the coordination of intra and inter-company projects.
• Enforces and influences internally and externally on matters pertaining to policies, plans, projects and objectives.
OTHER DUTIES AND RESPONSIBILITIES
• Manages validation projects and priorities by leading and mentoring team members.
MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor’s degree in Business, Engineering or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Experience
Minimum 3 years’ experience in validation process.
Skills
• Priority setting and ability to manage own time to be able to work on multiple projects simultaneously.
• In-depth knowledge and experience of medical device or pharmaceutical industry standards and requirements.
• In-depth knowledge of current industry expectations of validation requirements for process validation.
• Knowledge of all current cGMP/ISO requirements in the US and globally.
• Ability to pursue solutions and make decisions with a sense of urgency.
• Requires flexibility to adapt to and a willingness to learn new technologies.
• Ability to manage team members to deliver on time and on-budget results to customers.
▪ In-depth knowledge of documentation standards and validation processes and protocols.
• Ability to determine, present, and defend project requirements and status in a professional manner
Job Description
US FLSA: Exempt JOB CODE:ENG 0004 DATE MODIFIED: 15/oct/2021
JOB BAND: 9
The above statements are intended to describe the general nature of level of work being performed by people assigned to this classification. They
are not to be construed as an exhaustive list of all responsibilities duties, and skills required of associates so classified. All associates may be
required to perform duties outside of their normal responsibilities.
Page 2 of 2
• Knowledge of GMP and CRF part 11 for validation and development of life cycle.
• Knowledge of validation testing
• Demonstrated ability to communicate effectively both verbally and in writing.
-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.
PHYSICAL REQUIREMENTS Typical Office Environment requirements include reading, speaking, hearing, close vision, walking, bending and sitting. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional Physical Requirements
• Must be able to work non-standard hours and travel as business requirements.