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Job Description
Issue and maintain validation master plan and calibration plan.
Write validation protocols and reports.
Perform validation activities described in validation protocols including thermal studies, equipment and utilities validation.
Responsible for clean room qualification activities for classified areas and LAF units.
Maintain an up to date knowledge of validation requirements, practices and procedures.
Work with validation and metrology contractors when required.
Interact with manufacturing sciences and facilities / engineering departments to facilitate protocol execution as necessary.
Write validation master plans related to specific projects and coordinate project meetings related to execution of the validation master plan.
Write validation site specific and multi-site procedures.
Support implementation of validated system change requests and resolution of process deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval.
Read P and ID, Isometric and "as built" drawings.
Communicate effectively with supervisor and other department's workload, priorities, and issues to maintain validation schedule.
Set validation specifications for purchasing capital equipment.
Perform IQ/OQ on large automated systems.
Monitor safety programs to eliminate industrial accidents and follow up, maintain and ensure implementation of safety instructions and requirements in plant.
Formulate and recommend technical training programs based on knowledge of identified training needs, company production processes or changes in products, procedures or services.
Follow up, maintain and ensure implementation of GLP, GMP and GDP rules.
Enforce subordinates' participation and implementation of the EHS management system.
Skills
Bachelor’s degree in engineering, pharmacy or science.
From 5 to 8 years in in technical project management s in a pharmaceutical industry.
Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
Ability to solve practical problems.
Ability to work with mathematical concepts.
Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.
Excellent English, verbal / written communication.
Ability to work well through others.
Excellent computer skills.
Education
Engineering