Director of Validation

Director/Sr. Director of Validation. This position reports to the Vice President Consulting Practices and Marketing.

Responsibilities:

Provide guidance and leadership in all areas of Validation, including Commissioning and Qualification, Process Validation, Cleaning Validation, Analytical Instrumentation Qualification, Environmental Qualification and Monitoring as well as Methods Qualification.

•Function as an Industry Thought Leader and Subject Matter Expert on the topics listed above. This includes a thorough, demonstrated understanding of industry trends and standards, including Risk-Based Commissioning & Qualification, ASTM E-2500, 21CFR11, 21CFR210/211, 21CFR820, EudraLex Volume 4, Annex 1, Annex 11, and Annex 15.

•Assist in development of the Marketing and Sales policies and plans applicable to the practice and consistent with the rest of the organization.

•Assist Operations in staffing client projects to enable the company to execute the strategic plan efficiently and effectively, and to meet revenue goals based on personnel skills development and client needs.

•Development of technical documentation, including master and project plans, protocols and final reports, engineering documents and risk assessments to support client projects, including environmental monitoring, process validation, method validation, analytical instrumentation qualification and cleaning validation

•Ensuring compliance of process validation, analytical instrumentation qualification, environmental monitoring and cleaning validation operations to quality principles and GMP requirements, and participation in the development of quality systems through SOP writing and training.

•Write and publish “white” papers and blogs on the subject matter of the practice.

•Make industry association trade show and conference talks and presentation.

•Provide training and mentorship to clients and associates within other business units.

•Provide input to Sr. Management on niche marketing opportunities and overall strategic marketing conditions.

•Identify and develop new clients.

•Manage multiple projects.

•Promotes the firm’s reputation through good client relations.

•Extensive travel required.

 

Qualifications:

•B.S./B.A in scientific discipline (Engineering, Chemistry, Biology, Biochemistry, Microbiology or related life science)

•An advanced degree is preferred. Experience in business administration a plus.

•Minimum 12 years’ experience in pharmaceutical or biotechnology industry.

•Minimum 8 years “hands-on” experience performing environmental monitoring, process validation, method validation or cleaning validation studies, including the development and justification of environmental monitoring and cleaning validation plans.

•Ability to write and revise Standard Operating Procedures and analytical methods.

 

 

•Strong knowledge of applicable USP and ISO and other international standards. Read, prepare and analyze data for development of reports.

 

•Strong working knowledge of GMP principles including the Code of Federal Regulations (CFRs)

•Familiarity with ASTM E2500

•Supervisory experience preferred.

 

We offer a competitive salary and benefits package including: paid holidays, paid vacation and sick time, health and dental insurance, 401K plan, employer paid short and long term disability, flexible spending plan, and life insurance