Senior Validation Engineer

Dragon Recruiting

Canada

Ref: RP245-956

Job description / Role

Employment: Full Time

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 execution/documentation 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 and/or 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 (CAPA’s), and participation in audits and inspections.
• Participate on investigation teams in the event of adverse validation trends/failures to identify root cause and corrective/preventative 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:
• Bachelor’s 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 Bachelor’s 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, set/achieve timelines, direct/redirect 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, facilities/utilities, solution processes, sterilization, IT applications and/or controls systems/software
• Must have experience talking/dealing 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

About the Company

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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