Validation Engineer jobs in Rockville, MD

• Act as lead and simplify CQV functions, reports, and processes. 
  
• Support implementing safety programs for major capital projects. 
  
• Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects. 
  
• Initiate, author, revise, review and complete controlled documents for CQV projects.
  
• Review and qualify equipment for commissioning, qualification, and validation activities.
  
• Write and review GMP and GDP documents and technical specifications.
  
• Collaborate with multiple departments on assigned project activities and deliverables. 
  
• Initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, PQ, and OQ.
  
• Contact and work with contractors and vendors on assigned projects.
  
• Ability to travel as needed.
  
• Additional duties and responsibilities may be assigned from time-to-time. 

Requirements

• Bachelor's degree in Engineering or Life Sciences. 
  
• 5-7 years of applicable work experience in the biomedical and pharmaceuticals industry.
  
• Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, and PV documents. 
  
• Proficient in developing SOPs, final reports, and validation & quality policies.
  
• Strong experience developing and executing CQV protocols.
  
• Strong experience creating and maintaining CQV policies and processes. 
  
• Good understanding and complies with cGMPs and CFR21 part 11 guidelines.
  
• Demonstrated strategic thinking and implementation skills; proven analytical skills with ability to translate data to actionable plans; demonstrated ability to develop and implement marketing and product/service strategies by converting into tactical marketing plans; execute and deliver results 
  
• Excellent presentation and communication skills, written and oral, for a variety of audiences.
  
• Highly organized in planning and time management, with the ability to multi-task.
  
• Ability and willingness to travel is preferred.​
  

Benefits

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
  
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
  
• 401(k) and 401(k) matching - PSC matches, dollar for dollar, employees investment into the 401(k) plan up to 6%.
  
• PTO, Sick Time, and Paid Holidays
  
• Education Assistance
  
• Pet Insurance
  
• Discounted rate at Anytime Fitness
  
• Financial Perks and Discounts