Supervisor, Validation

High Point, NC - USA

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Excellent Benefits Package

Review our companys Total Rewards

Medical Dental & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

Location Information:

High Point NC

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How will you make an impact

The Supervisor Validation will be responsible for leading the day-to-day activities of the validation team in areas of Facility/Utility Lab Equipment Computerized Systems Cleaning and Process Validation. This role will provide technical support to internal and external customers; planning executing and analyzing validations; and managing site validation activities.

What will you do

Supervises daily operations of the Validation team specifically in the areas of Facility/ Utility/ Automation/ Laboratory/ Computerized Systems and Cleaning and Process Validation.
Responsible for the validation activities inclusive of the site validation master plan
Planning coordinating and leading the team to meet project requirements are adhered to.
Daily solving process optimization technical review of process issues and increased efficiency via continuous improvement measures.
Develop and implement related policies procedures and trainings to ensure consistency and efficiency. Assures that activities are conducted in compliance with US and EU regulations EHS requirements and global policies.
Sets measurable and achievable individual goals; leads and motivates team to achieve their targets.
Generate review and approval of protocols reports SOPs/WIs investigations risk assessments and change controls. Tasks include execution of validation data analysis and coordination support resources as needed.
Maintains inventory of GxP related equipment and associated periodic review activities.

REQUIREMENTS:
Advanced Degree no prior experience required or bachelors degree plus 5 years of experience in GxP regulated environment (Validation)
Preferred Fields of Study: Life Sciences or Engineering
Expert knowledge of GxPs GAMP CFRs/Annex 11 and Data Integrity requirements for laboratory systems and equipment
Strong understanding of Validation Lifecycle (GAMP 5) principles
Experience with calibration and maintenance management software
Knowledge of electronic document management systems
Experience with data integrity practices and compliance
Strong technical writing skills for qualification documents SOPs and work instructions
Ability to manage multiple projects simultaneously with minimal supervision
Detail-oriented with excellent verbal and written communication abilities
Ability to adapt to changing priorities in a deadline-oriented environment

Required Experience:

Manager

Work ScheduleStandard Office Hours (40/wk)Environmental ConditionsSome degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job DescriptionAs part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact...