What are the responsibilities and job description for the Validation Manager position at BOTG LLC?
Position: Validation Manager
Location: St. Louis, MO, USA
Duration: Fulltime
Our Work Matters
· Client make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
· The successful candidate will ensure products, processes and equipment comply with quality standards and regulations by leading a team of validation engineers and overseeing the validation activities, including testing, documentation, and compliance with cGMP and regulatory requirements for the entire lifecycle within the assigned site.
Role Responsibilities
· Develop and implement validation strategies and plans (VMPs) to ensure compliance with regulations and standards.
· Manage and execute equipment, facility, utility and process validation activities for the entire lifecycle within the assigned site.
· Collaborate with other departments (e.g. Operations, Quality, Automation, Engineering) to ensure alignment on validation activities and provide validation expertise and guidance.
· Ensure applicable process documentation is created, reviewed and in-place to ensure operation within validated parameters.
· Ensure proper change control in QTS (e.g. impact assessments, pre-approvals, interim reports and final approvals) are maintained throughout project execution.
· Participate in internal and regulatory audits for equipment, systems and processes validated in assigned site responsibility.
· Manage, train and mentor validation staff.
· Ensure validation activities are consistent with the quality standards, applicable recognized standards, site SOPs and cGMPs.
Basic Qualifications:
· Bachelor’s degree in a science, engineering or related field.
· 8 years of related experience or equivalent combination of education and experience.
· Experience managing direct reports.
· Strong understanding of cGMP, FDA regulations and validation principles.
· Proficient in MS Office Suite and other relevant software.
· Project management experience and skills.
· Strong analytical and problem-solving skills.
· Excellent communication and interpersonal skills.
Job Type: Full-time
Pay: From $60,000.00 per year
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Work Location: In person
Salary : $60,000
