Work Schedule Standard (Mon-Fri)Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materialsJob DescriptionWhen you join us at Thermo Fisher Scientific, you’ll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.The Senior Validation Engineer is responsible for the definition and implementation of qualification & validation processes in collaboration with Quality. He defines and implements processes for equipment and process qualification & validation to ensuring GMP standards are met.Position Responsibilities & AccountabilitiesTechnical Responsibilities
Prepares, reviews and approves production, validation, audit reports documents, procedures, and rationales.
Evaluates new regulations, changes to existing regulations and regulatory trends; prepares inspections and customer audit responses and reports; performs gap analysis to resolve efficiencies and take appropriate actions.
Defines, in collaboration with other partners (Quality Assurance, System Owner…) the requalification strategy of GMP systems and implements it, including maintaining the quality system and complete practical activities.
Coordinates execution of activities by external contractors.
Performs requalification and revalidation Work Orders, including routine and non-routine operations, and documents in forms and OMX following Good Documentation Practices
Participates in the culture of continuous improvement and development of technologies.
Identifies training needs and develop training programs.
Works in a safe and responsible manner in order to build an injury-free and incident-free workplace.
Participates in calibration activities
Quality
Adheres to general cGMP rules, Quality policies, procedures and instruction as rolled out by the Quality function and endorsed by the site management (Deviations, CAPAs, Change Control, etc.).
Actively chips in to continuous quality improvement initiatives and deviation reporting and follow-up.
Represent the department as SME for the responsible area in audits and regulatory inspections.
EHSS
Adheres to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site management.
Actively supplies to safety initiatives and issues as well as near miss reporting and follow-up.
Values & Behaviour
Maintains dedication to Thermo Fisher Scientific values and alignment with ethics and legal compliance standards.
Takes personal accountability for their presence, performance, and efficiency for the achievements of defined objectives.
Thinks and acts with a customer-centric mentality.
Is intellectually curious and accepts Practical Process Improvement (PPI).
Position QualificationsEducation
Bachelor’s degree in Biotechnology, Quality, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field.
Experience & Competences
Experience in the pharmaceutical industry for qualification & validation is required
Experience working in validation activities of steam sterilization processes and cleanroom qualification.
Additional Requirements
Ability to work independently and demonstrate job ownership.
Analytical and concept-based thinking and acting.
Physical ability to perform tasks that may require prolonged standing, walking, and lifting of materials and equipment.
Proficiency in working in cleanroom environments and adhering to all GMP and safety laws.
Proficient in the use of computerized office applications (e.g. Word, Excel, Outlook) and systems/business applications, project management and confirmed scientific writing skills.
Knowledge of cGMPs and FDA/industry expectations.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects an exciting company culture that stands for integrity, intensity, involvement, and innovation!Apply today!
