TOP/Drawing Support

Job ID: | Position Type: Project Based, Full-Time

location

Novato, California

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.

Duration: 3 – 6 Months

Duties:

  • As part of Pharmatech’s consulting teams, provide validation and consulting services to clients in the regulated life sciences industry: pharmaceutical, biotech and medical device companies
  • Review current state of drawings and Turnover Packages at client site.  Document gaps identified and work with client team to plan remediation activities
  • Generate documents and coordinate by constant communication with affected departments and personnel to ensure remediation activities are completed

Qualifications:

  • BS. with a scientific or engineering related major is required
  • Minimum 2-8 years of validation work experience with demonstrated know-how of process equipment, automation system, facility and utility qualifications and project management
  • Understanding of the validation life cycle and solid experience with IQ, OQ, PQ, DQ protocol generation and execution
  • Must be able to read and understand Piping and Instrumentation Diagrams (P&IDs)
  • Must understand the purpose, content, and structure of Turnover Packages
  • Must be proficient 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 able to work independently with limited supervision
  • Exceptionally motivated and well organized with attention to detail
  • Advanced computer skills and knowledge of Microsoft Office products required

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