The primary purpose of this job is to support major Manufacturing Engineering Projects.
The position is part of a team within the Engineering department that contributes to the overall business metrics. This position will provide project leadership on continuous improvement, and risk mitigation initiatives and will also include liaison with outside suppliers and other Design & Manufacturing sites to ensure all goals and targets of the manufacturing process are achieved
* Competent in validation requirements on new processes, equipment introductions & process changes.
* Responsible for performing process validation studies by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
* Process Validation for process creation
* Process Validation for the transfer of processes within the facility.
* Defines the requirements for Process Validation studies in alignment with approved SOPs.
* Executes test plans according to approved procedures, performs sampling, tabulates test results, and organizes data packages.
* Compiles and analyses validation data, prepares reports and makes recommendations for changes and/or improvements.
* May also investigate and trouble-shoot problems which occur, and determine solutions.
* Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.
* Maintains and archives all documentation pertaining to validation.
* Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.
* As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies.
* Independently applies validation principles to work assignments, reviews and approves documents and resolves problems.
* Coordinates assigned projects and represents department on project teams.
* Resolves validation issues of moderate scope with limited direct supervision.
* Ability to manage multiple assignments or projects with sound analytical, troubleshooting, and problem solving skills.
* Flexible work ethic and influencing skills.
* Problem solving skills - to assist in maintaining project progress and on design issues.
* Decision Making - required to make decisions on technical issues.
* Degree of responsibility - must be capable of taking direction and taking responsibility and ownership for systems.
* Excellent planning & organisation skills.
* Extent of confidentiality - discretion is essential in view of contact with outside parties, product development strategies, regulatory and sales information.
* Continuous Improvement Focus
Qualifications & Experience:
* Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation.
* Proficient in current Good Manufacturing Practices (GMPs).
* Full knowledge of industry practices.
* Strong verbal, written, and interpersonal communication skills are required.
* Investigation and report writing skills.
* Proficient in Microsoft Office applications.
* Degree qualified in a relevant Engineering / Science discipline, with 5+ years relevant experience.
* Experience in Statistical analysis is essential.
* Experience in regulated industry, FDA, ISO, etc.
* Demonstrated leadership skills and the ability to make effective decisions
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists