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Validation Engineering Specialist I

4 months ago

Whitby, Canada Thermo Fisher Scientific Full time

Provides specialized validation knowledge and information, which is directly needed to support operations and clients. Complete protocols and reports related to the validation of manufacturing processes, packaging processes (including serialization), equipment qualification and cleaning. Ensures documents conform to all ThermoFisher Standard Operating Procedures (SOPs), client requirements and Good Manufacturing Practices. Job tasks are clearly defined but timing or priority decisions must be made sometimes where challenging demands must be balanced.

What will you do:

• Prepares Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for equipment, facilities and computer systems. 

• Prepares and executes validation protocols (new and existing clients) and writing reports.

• Collects/verify and analyzes data. 

• Performs 5 years qualification reviews.

• Provides technical support to Quality Operations, Business or Project management and Operations.

• Supports special projects (as required).

• May perform alternating or rotating shifts (as required).

How will you get here:
Education:
Minimum post-secondary diploma in Chemistry, Engineering, Science or related field.
BSc in Chemistry or Engineering is an asset.

Experience:
Minimum 1 year experience in validation within the pharmaceutical industry. 

Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered. 


Knowledge, Skills and Abilities:
Strong written and oral skills. Detail oriented and organized, with a high degree of accuracy and 
thoroughness. Excellent interpersonal skills, communication and organizational skills. Strong judgment, decision making and trouble shooting skills. Ability to multi-task, meeting tight deadlines in a fast paced environment. Mini-T and data analysis knowledge an asset. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.


Core Competencies:
Put the Customer First - Think and act with a customer-centric mindset to deliver exceptional customer experiences. Own Your Results - Take personal accountability for all you do and always exercise good judgement. Find a Better Way Every Day - Be intellectually curious and embrace Practical Process Improvement (PPI).


Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

Benefits:

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company savings plan, and a range of employee benefits Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.