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Senior Validation Engineer

Your role:

 

The Senior Validation Engineer provides successful completion of validation activities with minimal oversight for laboratory equipment and controlled temperature units meeting regulatory/company requirements per the prioritized timeline. 

  • Responsible for the successful execution of qualification activities of equipment to include controlled temperature chambers and analytical systems
  • Scope of work to include a range of small individual projects of low complexity to large complex projects with numerous validation deliverables
  • Presents results to program team (multi-disciplinary/cross-departmental) 

 

Physical Attributes:

  • While performing this job, the employee may be exposed to moving mechanical equipment, harsh and/or toxic chemicals and biologicals, extreme cold (-70C) and noise in excess of 100 decibels
  • Must be able to walk, stand, reach above the shoulders, use a cellular phone, use feet to operate equipment, stoop, kneel, crouch or crawl, talk, hear, use hands to operate tools and equipment
  • Must be able to lift and/or move up to 40 pounds unassisted and additional weight with assistance. 
  • Vision requirements include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus
  • The employee may be required to wear a hardhat, safety shoes, eye protection, hearing protection, a safety harness, and protective clothing and gloves, respirator and face shield
  • Must have valid driver’s license and requires operation of company vehicles
  • Must be able to work at varying heights

 

Who you are:

Minimum Qualifications:

  • Bachelor’s degree in a scientific discipline (i.e. Biology, Chemistry, etc.) or a technical field (i.e. Mechanical Engineering, Chemical Engineering, etc.) with 5+ years hands-on validation experience

 

Preferred Qualifications:

  • 3+ years’ experience working in a GxP environment
  • Experience performing CTU and or analytical system qualifications
  • Positive attitude
  • Experience in managing projects of varying complexity
  • Strong independent problem-solving skills
  • Experience with OE/CI principles
  • Experience and working knowledge of Microsoft programs, CMMS (Blue Mountain RAM, Q&A and/or SAP) 
  • Excellent written and verbal communication skills
  • Ability to prioritize multiple projects

 

Job Requisition ID:  209943
Location:  Rockville
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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