Senior Validation Engineer

Job ID: | Position Type: Full Time, Exempt

location

San Francisco Bay Area

At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions.  We are committed to fostering an environment that is professional and forth right.  These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success.   We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance.  At Pharmatech talent matters, and we tackle each project with a “no fear” attitude.  We stand together as a team, and we’ve got your back.  Pharmatech’s commitment to integrity is unwavering.

Duties:

  • As part of Pharmatech’s consulting teams, provide validation services to clients in the regulated life sciences industry: pharmaceutical, biotech and medical device companies
  • Prepare and execute protocols for equipment, facility, utility, and cleaning validation work (IQ, OQ, PQ, & DQ)
  • Supervise and train junior level validation engineers
  • Oversee multiple validation projects and budgets at a given client site
  • Perform validation master planning and lead validation strategic planning efforts
  • Oversee and review validation area processes and procedures
  • Coordinate all validation activities by constant communication with affected departments and personnel
  • Manage client relations

Qualifications:

  • B.S. with a scientific or engineering related major is required
  • 5+ years of validation work experience with demonstrated know-how of solid dosage process equipment, automation system, facility and utility qualifications and project management
  • Thorough understanding of the validation life cycle and solid experience with IQ, OQ, PQ, DQ protocol generation and execution
  • Knowledge of Risk Assessment
  • Proven ability to mentor and oversee junior validation engineers
  • Experienced proficiency with GDP, GEP, and cGMPS
  • Outstanding communication (written and verbal) and interpersonal skills with the ability to work in a team environment is a must
  • Excellent technical writing skill is critical
  • Must be exceptionally motivation, able to work independently and function in a team environment
  • Advanced computer skills and knowledge of Microsoft Office products required
  • Willingness to work at various client sites both in and out of California with possible extended travel

 


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