Senior Validation Engineer - 2312308

Dragon Recruiting
  • Senior Validation Engineer Jobs in Canada - 2312308

    Dragon Recruiting
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2312308

Job Description

Responsibilities

Work closely with Validation Change Owners to plan, write and support execution of validation documents (IQ, OQ, IOQ, PQ etc) that are compliant with Plant and Corporate policies and procedures; ensure proper executiondocumentation of test results, and compilation of validation packages Responsible for reviewing, executing and approving validation documents

Present or work closely with the Validation Change Owners to present proposed validations to the Plant Validation Review Board (VRB) and support validations to regulatory and third party representatives during inspections and audits

Ensure validation packages contain all relevant information, rationales, references, and data to support the change and that all reports and protocols are reviewed and approved as appropriate

Initiates, leads and authors cGMP risk assessment, gap analysis, and deviation management associated with validation programs with precise document writing following Good Documentation Practices (GDP) with clarity to meet the set forth expectations

Ensure Validation Plans and strategies are in alignment with validation policies, procedures and guidelines and external regulatory requirements, and European and International standards

Plan and lead re-validation of existing plant equipment, facilities, utilities, processes, control systems, software, cleaning, etc

Serves as Change Owners for periodic reviews, and remediation activities on validated systems Plans andor executes these validation protocols

Accountable for compliance of the site validation programs via documentation completion, risk assessments, proactive identification of risks issues, review of protocols and reports, closure of preventative and corrective actions (CAPAs), and participation in audits and inspections

Participate on investigation teams in the event of adverse validation trendsfailures to identify root cause and correctivepreventative actions Expected to bring validation expertise and strong analytical and systematic problem solving skills

Create tables, charts and graphs using standard MS Office software (Word, Excel, Power Point, Outlook) to represent data or information in validation or research activities

Supervise validation technician(s) and validation consultants to provide project and technical direction, as needed

Serves in the role of Validation Manager or Section Manager in their absence

Provides technical training in validation to plant personnel

Write or assist with the writing of Standard Operating Procedures and Validation Master Plans

Review and provide feedback to plant and corporate policy writers on new and revised validation guidelines, specifications and policies

Perform other related duties as assigned or required

Interact with QA, IT, Engineering and business area users to understand functionality and use of automated control systems

Work on special projects as they arise

Benefits

Attractive Salary Package


REQUIREMENTS

Education and Experience

Bachelors Degree is required Engineering (Mechanical, Chemical, Electrical, or Biomedical) or related science

Incumbent must have a minimum of five (5) years experience in a pharmaceutical GMP environment

Must have a minimum of three (3) years direct validation experience

Candidates with other technical Bachelors degrees will be considered if they have five (5) or more years of direct validation experience

A minimum of two (2) years of supervisory experience is required

Requires a high level of resourcefulness, an ability to get things done by removing obstacles, perceiving and resolving problems, making difficult decisions with less than complete information provided, and finding ways to accomplish goals through innovative planning

Must maintain a thorough working knowledge of the ICU Medical Specification Systems

A high level of attention to details and the ability to proofread and audit validation documents is required

Must be able to work weekends and holidays as required to meet deadlines

Must be able to manage complex projects, setachieve timelines, directredirect resources and manage assigned funding

Knowledge, Skills & Qualifications

Must have thorough knowledge and understanding of cGMPs, FDA and pharmaceutical industry guidelines

Expertise in one of the following disciplines is required manufacturing, facilitiesutilities, solution processes, sterilization, IT applications andor controls systemssoftware

Must have experience talkingdealing with regulatory and third party representatives

Must have good organizational, presentation, meeting facilitation and technical writing skills

Working knowledge of statistics is preferred

Minimum Qualifications

Must be at least 18 years of age

Must pass pre-employment drug screen and background check

Travel REQUIREMENTS

Typically requires travel less than 5% of the time

Physical REQUIREMENTS and Work Environment

Generally an office environment

Some physical demands when working on the manufacturing floor executing validation runs

Must be able to lift up to 25 lbs unassisted

Profile Summary

Type:Company Job

Deadline:13th Sep 2024

Company Profile

Dragon Recruiting is a leading international staffing and recruitment company, head-quartered in London, with further offices all over the globe. Our clients range from numerous well known UK and international businesses. We also represent a wide range of less well known clients - helping them to find staff for their businesses around the world.
As an international recruitment agency, our clients benefit from a vast network of human resource specialists who attract, cultivate and connect organisations to talent in both global and local markets. Our unrivalled
scope of services and global reach allow us to share candidates and roles across borders. With greater coverage and tools, we can ensure our clients and candidates all get the best outcome for their recruitment needs.
With experience of over 3 decades we are recruiting more than 10,000 workers annually to and from the UK, USA and the Middle East and several other Asian countries. We specialize in the placement of candidates in permanent, contract, temporary and interim positions with clients around the world.



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