Validation Engineer

Longmont, Colorado, United States Full-time

Position Title: Validation Engineer
Job Location(s): Longmont, CO
Start Date: ASAP
Employment Type: Full Time
Starting Salary Range: Competitive
Job Requisition #: 18053

Avista Pharma Solutions is a contract testing, development and manufacturing organization (CDMO) encompassing over 200,000 square feet of laboratory and manufacturing space across the U.S. and U.K. (Agawam, MA – Durham, NC – Longmont, CO – Edinburgh, Scotland), providing pharmaceutical, animal health and medical device clients with a broad suite of scientifically-differentiated services.

DUTIES:

  • As a Validation Engineer, you will be responsible for Quality Assurance oversight of validation and qualification of equipment, utilities, facilities, and software programs that are used in the GMP environment at Avista Pharma Solutions.
  • You will develop, review, and approve qualification and validation (IQ, OQ, PQ, PV) documentation and ensure they are written in accordance with the Avista Pharma Solutions and industry standards.
  • You will oversee and work with Manufacturing, Quality Control, Facilities, IT, and Materials Management in the implementation of validation activities and to design and draft validation and qualification protocols.
  • As a Validation Engineer, you will take part in the establishment, implementation, follow-up, and maintenance of continuous validation plans and assist in the development of Facility, Equipment, and Utility maintenance plans that address each type of equipment or system on a scheduled basis.


QUALIFICATIONS:

  • Bachelor’s Degree or higher required.
  • 5-10+ years of experience in a pharmaceutical environment working with the validation and qualification of equipment, utilities, facilities, and IT systems. Cleaning validation experience is highly preferred.
  • Highly knowledgeable in the functional operation of equipment used in the production of active pharmaceutical ingredients.
  • Strong background in GMP environment.


SUCCESS FACTORS:

  • Ability to learn how equipment functions and then design appropriate validation / qualification protocols.
  • Knowledgeable in computer programs including Microsoft Word and Excel.
  • Ability to work effectively within a team environment and exhibit leadership skills.

 
Avista Pharma Solutions is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.