2 Manager, Validation Jobs in High Point, NC
Sorry! This job is no longer available. Please explore similar jobs listed on the left.
myGwork - LGBTQ+ Business Community is Hiring a Manager, Validation Near High Point, NC
OtherEnvironmental Conditions
Office
Job DescriptionAs part of the Thermo Fisher Scientific team, you'll 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 world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Excellent Benefits Package
Review our company's 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
How will you make an impact?
The Manager of Technical Services and Validation will be responsible for leading the day-to-day activities of the technical team. This role will provide technical support to internal and external customers; planning, running, and analyzing trials; managing a team passionate about supporting robust processes, product life cycle and managing site validation activities. This includes supporting process development activities and registration, supporting scale-up of commercial production and transfer to lifecycle support, and ongoing validation activities.
Essential Duties And Responsibilities
- Manage Risk Analysis, Scale-up/Transfer trials, and support complex Validation activities.
- Support production staff, including assessment of investigations, implementation of path forward, and determination of product impact.
- Supervises daily operations of the Technical Services and Validation (Process/CPV/Cleaning/ Equipment/Utility/Automation/Laboratory) team.
- Responsible for all validation activities inclusive of the site validation master plan
- Responsible for the cleaning validation program to ensure best practices in developing CIP and manual cleaning procedures.
- Responsible for supporting manufacturing of pre-commercial development batches and identifying areas of process improvements.
- Planning, coordinating, and leading the team to meet project requirements and budget targets are adhered to.
- Daily solving, process optimization, technical review of process issues and increased efficiency via continuous improvement measures.
- Assists with the development and management of related policies, procedures, and protocols to ensure consistency and efficiency. Assures that activities are conducted in compliance with US and EU regulations and EHS requirements.
- Sets measurable and achievable individual goals; leads and motivates team to achieve their targets.
- Reviews and approves documents prepared by the team. Writes protocols, batch records, assessments, change controls, and summary reports as needed. Collects samples, analyzes data, and coordinates support resources, as needed.
- Maintains inventory of GxP related equipment and associated periodic review activities.
- Ability to train, mentor, and coach others.
- Experience and interpretation of statistical process control
- Good communication (oral and written), organizational and time management skills.
- Support technical activities at the plant level to ensure regulatory compliance and efficiency of facilities, equipment, and processes.
- Apply cGMP regulations and guidelines to all aspects of validation / qualification activities.
- Professional knowledge and experience with gap analysis, GxP requirements, FMEA, and FDA/EMEA requirements applicable to the pharmaceutical industry. .
- Experience with supervision, all types of validations, maintaining processes and equipment in a validated state.
Bachelor's Degree in Science or Engineering and at least 6 years of validation experience, prefer at least 1 to 2 years of management experience. Shown success working across organizations in highly matrixed / team environment. Validation experience with startup and maintenance of automated pharmaceutical manufacturing systems.
Familiarity with applicable US and worldwide regulatory requirements for the pharma industry.
Job Summary
Full Time
$132k-164k (estimate)
07/27/2024
08/23/2024
The job skills required for Manager, Validation include Planning, Continuous Improvement, etc. Having related job skills and expertise will give you an advantage when applying to be a Manager, Validation. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Manager, Validation. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Manager, Validation positions, which can be used as a reference in future career path planning. As a Manager, Validation, it can be promoted into senior positions as a Reliability Engineering Sr Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Manager, Validation. You can explore the career advancement for a Manager, Validation below and select your interested title to get hiring information.
Similar Jobs
Popular Articles
