Validations Specialist

AAIPharma Services   •  

Charleston, SC

Industry: Business Services

  •  

5 - 7 years

Posted 391 days ago

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What differentiates us at Alcami?  Our people.

Help shape the future of medicine and join us – we are a pharmaceutical contract development manufacturing organization (CDMO).

Alcami Corporation is the first company to offer a solution that is tailored to small and mid-size pharmaceutical and biotechnology companies. We offer a range of services from four distinct pillars: Development Services, Analytical Testing, Drug Product, and APIs. Beyond that, we can integrate our services so customers experience a simplified engagement with a single project management relationship, full visibility from development into manufacturing, and shorter turnaround times. With six locations in the U.S. and a global location in The Netherlands, the Alcami family is growing rapidly. Picture yourself at Alcami and apply today.

Our sterile manufacturing facility is located in Charleston, SC, a vibrant city well-known for its coastal beauty, climate, cultural arts, and thriving business environment.  Recently, Charleston received 1st place honors as the “Most Livable City in America” (US Conference of Mayors). 

Position Overview:

The Validations Specialist will support general pharmaceutical validation activities at our sterile manufacturing facility.

Key Responsibilities:

  • Drafting initial SOP’s for the process and manufacturing equipment.
  • Validating revised SOP’s and performance validation master plans.
  • Supporting manufacturing equipment cleaning and process validation projects.
  • Conducting reviews of validation documentation such as equipment checklists, process flow diagram reviews, validation plans as per user, system and functional requirements, study protocols and summary reports;
  • Monitoring compliance in manufacturing adjustments as per validation guidance.
  • Developing documentations as required for projects.
  • Consulting on validation and cGMP questions and issues. 
  • Performing the qualification and validation of equipment and systems.
  • Assisting in equipment selection, specification, and negotiation of competitive pricing by tracking and comparing vendor costs.

Qualifications for success:

Qualifications include BS degree in a science related field with 5+ years of related validations pharmaceutical experience. This position requires strong knowledge of quality assurance and/or engineering reviews of validations documentation, experience in a pharmaceutical GMP aseptic environment, cGMP training and knowledge, and excellent communication and computer skills.

 

What we offer you:

  • Profit sharing bonus plan
  • Medical, dental and vision coverage from day one
  • A menu of voluntary benefits including short & long term disability, life, accident, critical illness and hospital indemnity insurances
  • Paid/flexible sick-leave, vacations, and holidays so you can take the time when you need it
  • To complement your personal financial strategy, we also have 401(k) matching
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