This role will Provide engineering support for maintenance and validation activities. Maintain engineering documentation and support the completion and maintenance of both equipment impact and instrument assessments. Whilst complying & adhering to Good Manufacturing Practice (GMP) standards.

Main tasks and responsibilities

• Manages the scope, deliverables, schedule, budget and quality of maintenance/engineering projects related to cGMP process equipment, utilities, controls and physical building. This may include generation/review of design documentation, participation in both factory and site acceptance testing, participation in equipment installation and facility construction activities.
• Responsible for the identification and mitigation of risks to ensure business continuity and protect the company from loss.
• Responsible for preparation and presentation of project status reports.
• Recommends and manages implementation of appropriate corrective/preventative actions for existing equipment and manufacturing processes.
• Evaluates, approves, prepares, and executes change control documentation, including like­ for-like component assessments.
• To provide support and recommend continuous improvement initiatives utilizing lean manufacturing tools and/or other techniques.
• Maintains compliance with applicable local, state, and federal regulations.
• Performs other related duties as required and assigned.

Qualifications and experience required for competent performance

• BS Degree in Engineering and one to three years Validation experience in a cGMP/cGLP regulated environment; or equivalent combination of experience, education and training.
• Bachelor of Science or specialty degree/certification from a vocational institution. Degrees related to information systems/technology is preferred.
• Minimum of one (1) year of working with CAD, or other graphical software packages. Alternately, formal training on CAD, or other graphical software package.
• Minimum of one (1) year of working in a FDA regulated GxP environment, an ISO 9002 environment, or other regulated environment with a defined quality system (e.g. - nuclear).
• Fluent in communications (verbal/written) in English
• Ability to work with mathematical typical concepts and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.