What are the responsibilities and job description for the SUD Validation Engineer position at myGwork - LGBTQ Business Community?
This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly.
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As 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.
Location/Division Specific Information:
This role is in the Single Use Division and will be performed at our Logan, Utah location.
How You Will Make An Impact
Ensure systems meet regulatory requirements, company procedures, and data integrity standards. Lead validation activities and impact assessments. We are seeking a highly skilled and motivated Validation Engineer to join our dynamic team. Your responsibilities will involve leading validation activities spanning Process and Product Validation, Sterilization, Stability, and Computer Software Validation (CSV). This role necessitates a collaborative approach to work seamlessly with multi-functional teams, motivating change and ensuring the timely and compliant execution of all validation phases. The preferred candidate will have in-depth understanding of manufacturing processes and validation systems, inspiring change management processes and upholding compliance with regulatory requirements.
A Day In The Life
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As 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.
Location/Division Specific Information:
This role is in the Single Use Division and will be performed at our Logan, Utah location.
How You Will Make An Impact
Ensure systems meet regulatory requirements, company procedures, and data integrity standards. Lead validation activities and impact assessments. We are seeking a highly skilled and motivated Validation Engineer to join our dynamic team. Your responsibilities will involve leading validation activities spanning Process and Product Validation, Sterilization, Stability, and Computer Software Validation (CSV). This role necessitates a collaborative approach to work seamlessly with multi-functional teams, motivating change and ensuring the timely and compliant execution of all validation phases. The preferred candidate will have in-depth understanding of manufacturing processes and validation systems, inspiring change management processes and upholding compliance with regulatory requirements.
A Day In The Life
- Assess and resolve system-related issues in these areas.
- Apply expertise to lead changes in electronic batch records and manage change processes.
- Lead the lifecycle and change management of these processes, ensuring consistency.
- Conduct complex validation activities for computers, equipment, products, stability, and processes.
- Ensure scalable, flexible, and consistent solutions globally, coordinating with global counterparts.
- Support product sterilization and validation efforts.
- Coordinate validation-related audits and provide technical defenses.
- Determine requirements and resolve issues for system validation, planning necessary resources.
- Act as the principal technical expert for validation.
- Represent validation in project teams, ensuring CGMP compliance and interdepartmental consistency.
- Ensure regulatory compliance by interpreting and applying relevant requirements.
- Stay updated on emerging trends and technologies, serving as a technical resource.
- Demonstrate strong interpersonal and communication skills, collaborating effectively.
- Coordinate and provide training for team members' career development.
- Perform additional duties as assigned.
- Minimum Required Education: Bachelor’s Degree in Science or Engineering fields.
- Required: 8 years of experience in validation engineering
- Advanced Statistical knowledge.
- Knowledge of IT/CSV methodologies; GAMP5, ISO 13485, 21 CFR Part 11, Annex 11, and Data Integrity.
- Strong history of involvement with Validation lifecycle activities in regulated environments.
- Ability to comprehend complex technical concepts.
- Outstanding written and verbal communication skills for effective engagement across all organizational levels.
- Annual performance-based bonus
- Annual merit performance-based increase
- Benefits & Total Rewards | Thermo Fisher Scientific
- Medical, Dental, & Vision benefits - Effective Day 1!
- Paid Time Off & Designated Paid Holidays
- Retirement Savings Plan
- Tuition Reimbursement
- Employee Referral Bonus
- Career Advancement Opportunities
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