Validation Manager position for one of our direct client n..

Validation Manager Job Description

Position Overview:

This position is responsible for Managing Validation projects. The
Validation Lead is responsible for maintaining compliance to the GxP
procedures.

1. Plan and schedule validation projects. Lead the development and
execution of validation project strategies for a wide range of
processes, systems and equipment, consistent with Corporate Directives
and regulatory expectations crossing Engineering, Technical Services,
Manufacturing, QA/QC and Regulatory disciplines;

2. Responsible for defining scope of work, resources and duration
for individual projects to meet validation and budgetary goals.
Monitors all project expenditures and cost tracking.

3. Manage, identify, hire, develop and recognize technical staff to
supportg validation activities. Provide technical direction.

4. Responsible for Validation policies and defining procedures for
the staff in accomplishing and documenting projects. Provides input on
overall Validation Department policy.

5. Provide departmental and site management with periodic site
Validation status updates.

6. Support facility inspections, audits (both performed by internal
groups and by regulatory agencies), and annual product reviews.

7. Approve protocols and support documentation (engineering change
requests, system change forms, etc.) in order to secure project
release.

Desired skills / certifications / training

1. Minimum 9 -12 years of Pharmaceutical and/or Biotechnology
experience including facility, utility, process, and equipment
validation experience, and min 5 years supervisory/managerial
experience, or an equivalent combination of education and experience.
Managerial experience in handling multiple projects and leading cross-
functional teams.

2. Knowledge of cGMPs, FDA and EMA guidelines, quality systems and
process validation.

3. Recognized as highly proficient and successful in validation
field. Be involved in at least one industry interest group.

4. Has demonstrated effective managerial / supervisory skills.

5. Must be self-motivated, have good interpersonal skills, capable
of analyzing and solving complex problems through innovative thought
and experience. Working experience in statistical methods (MVDA) and /
or DOE is desirable.

6. BS in related engineering discipline or other scientific based
discipline with advanced technical degree or equivalent experience.

When applying please mention the JOB ID NUMBER.
Please send your updated Resume with your references to
jobs DeleteThis @mapleresource.net