- Develop and implement comprehensive validation strategies for processes, systems, and equipment.
- Ensure alignment of validation activities with regulatory requirements and industry best practices.
- Create and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Performs Process Characterization (PC) and Test Method Validations (TMV)
- Establish and maintain a centralized repository of validation documentation. (PFMEA, MVP, MVR)
- Oversee the validation of complex manufacturing processes and cleaning procedures, ensuring a high level of scrutiny and adherence to quality standards.
- Utilize data analysis to drive continuous improvement initiatives within validated processes.
- Conduct risk assessments to identify critical validation requirements and areas of potential impact.
- Collaborate with cross-functional teams to implement risk mitigation strategies.
- Lead equipment qualification activities, ensuring that manufacturing equipment meets specified requirements.
- Collaborate with equipment vendors to validate new or upgraded equipment.
- Coordinate and conduct validation testing, including the execution of test scripts and the collection of data.
- Analyze test results and ensure deviations are appropriately documented and addressed.
- Utilize statistical methodologies to analyze validation data, ensuring robust conclusions and effective decision-making.
- Implement statistical tools and techniques to enhance the reliability and efficiency of validation processes.
- Provide training to junior validation engineers and other relevant personnel.
- Act as a subject matter expert and mentor team members on validation best practices.
- Bachelor's degree in Engineering or a related field. Master's degree is a plus.
- 7+ years of experience in validation within a regulated industry (Pharmaceutical, Medical Devices)
- Catheter Manufacturing is a plus
- In-depth knowledge of validation principles, methodologies, and regulatory requirements (FDA, ISO, etc.)
- Manufacturing or sustaining experience.
- Strong experience in developing and executing validation protocols.
- Proficiency in risk assessment and mitigation strategies.
- Excellent analytical and problem-solving skills. (Black Belt is a plus)
- Exceptional communication skills, with the ability to collaborate effectively across teams.
- Continual improvement process experience.
- Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment.
-
Validation Engineer
3 weeks ago
Kinovate Life Sciences Inc Carlsbad, United StatesJob Description · Job Description · The Validation Engineer is responsible for design, planning, writing, and execution of protocols and studies at Kinovate Life Sciences. The perfect candidate is responsible for managing, coordinating, facilitating, and implementing process, e ...
-
Validation Engineer
3 weeks ago
PSC Biotech Carlsbad, United StatesJob Description · PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to skyrocket our ...
-
Validation Engineer
2 weeks ago
PSC Biotech Carlsbad, United StatesJob Description · PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to skyrocket our c ...
-
Validation Engineer
3 weeks ago
Kinovate Life Sciences, Inc. Carlsbad, United StatesJob Description · Job DescriptionThe Validation Engineer is responsible for design, planning, writing, and execution of protocols and studies at Kinovate Life Sciences. The perfect candidate is responsible for managing, coordinating, facilitating, and implementing process, equipm ...
-
Validation Engineer
2 weeks ago
Kinovate Life Sciences, Inc. Carlsbad, United StatesJob Description · Job DescriptionThe Validation Engineer is responsible for design, planning, writing, and execution of protocols and studies at Kinovate Life Sciences. The perfect candidate is responsible for managing, coordinating, facilitating, and implementing process, equipm ...
-
Senior Validation Engineer
2 weeks ago
Bolt Medical Carlsbad, United StatesDIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES. · RECRUITERS: DO NOT CONTACT. · SUMMARY OF THE JOB · As a Senior Validation Engineer, you will play a critical role in ensuring the quality and compliance of products by developing and implementing ...
-
MMR Consulting Inc Carlsbad, United StatesJob Description · Job Description Salary: · Previous · Pharmaceutical/Biotech · experience is mandatory for this role. · MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Pro ...
-
Consultys Carlsbad, United StatesMissions · Join our team as a Commissioning and Qualification Engineer and play a crucial role in the successful execution of commissioning and qualification activities for pharmaceutical/biotech manufacturing facilities. In this role, you will generate test packages, coordinate ...
-
Engineering Technician C
1 week ago
L3Harris Technologies Carlsbad, United States**Job Title: Engineering Test Technician C** · **Requisition ID**:10573** · **Job Location: Carlsbad, CA** · L3Harris' Communication Systems segment is currently seeking a Engineering Technician C to join our team on 1st shift. This position will be based at our Carlsbad, Califor ...
-
Engineering Technician D
1 week ago
L3Harris Technologies Carlsbad, United States**Job Title: Engineering Test Technician D** · **Requisition ID**:11229** · **Job Location: Carlsbad, CA** · L3Harris' Communication Systems segment is currently seeking a Engineering Technician C to join our team on 1st shift. This position will be based at our Carlsbad, Califor ...
-
Hardware Technician
2 weeks ago
Arlo Carlsbad, United StatesArlo is an award-winning, market leader in the smart home IoT category that is focused on bringing together deep expertise in product design, wireless connectivity and RF engineering, cloud infrastructure and leading-edge AI capabilities to create a seamless smart home experience ...
-
Production Control Planner
3 weeks ago
Viasat, Inc. Carlsbad, United StatesAbout us: · One team. Global challenges. Infinite opportunities. At Viasat, we're on a mission to deliver connections with the capacity to change the world. For more than 35 years, Viasat has helped shape how consumers, businesses, governments and militaries around the globe comm ...
-
Summer Science Instructor
3 weeks ago
Hands-On Technology Education Carlsbad, United States**Hands-On Technology Education, LLC (HOTE) **seeks to provide safe, engaging, and balanced STEAM-based summer activities for elementary, middle, and high-school students with a focus on introducing Technology and Computer Engineering in fun and interactive ways. · **Training Dat ...
-
Manager, Field Engineering
1 week ago
Viasat, Inc. Carlsbad, United StatesAbout us: · One team. Global challenges. Infinite opportunities. At Viasat, we're on a mission to deliver connections with the capacity to change the world. For more than 35 years, Viasat has helped shape how consumers, businesses, governments and militaries around the globe comm ...
-
Technical Writer Iii
1 week ago
Thermo Fisher Scientific Carlsbad, United StatesAs 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 ou ...
-
Project Manager
3 weeks ago
Nevell Group Carlsbad, United StatesPROJECT MANAGER · **Summary**: · This position is responsible for the effective management of site projects, leveraging extensive knowledge of construction management principles and demonstrated mastery of communication and workflow coordination. Execute strategically coordinated ...
-
Director of Technical Marketing
2 weeks ago
MaxLinear, Inc. Carlsbad, United States**Responsibilities**: · MaxLinear is seeking a Director of Technical Marketing to join our growing team. In this role, you will focus on working with customers to help translate their product evolution to high-level technical requirements. You will then guide the systems and engi ...
-
Engineering Manager
2 weeks ago
Hilton Garden Inn Carlsbad Beach Carlsbad, United StatesProperty Description: · Hilton Garden Inn Carlsbad Beach is a premier hotel located in Carlsbad, California, offering exciting job opportunities for motivated individuals. Joining the team at Hilton Garden Inn Carlsbad Beach means becoming part of a renowned hospitality brand kno ...
-
Manufacturing Sciences Scientist Iii
2 weeks ago
Thermo Fisher Scientific Carlsbad, United StatesOur Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working ...
-
Account Manager, Itad
1 week ago
Camston Wrather LLC Carlsbad, United StatesCamston Wrather is a pioneering science and engineering firm based in Carlsbad, CA that specializes in extracting valuable resources from electronic waste through cutting-edge Green Tech. Our expertise lies in the recovery of sustainable materials like precious metals and polymer ...
Senior Validation Engineer - Carlsbad, United States - Bolt Medical
Description
DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.
RECRUITERS: DO NOT CONTACT.
SUMMARY OF THE JOB
As a Senior Validation Engineer, you will play a critical role in ensuring the quality and compliance of products by developing and implementing robust validation strategies. Your expertise will be essential in verifying and documenting that processes, systems, and equipment meet regulatory and quality standards. This position requires a seasoned professional with a deep understanding of validation principles, excellent problem-solving skills, and the ability to collaborate across cross-functional teams.
ESSENTIAL DUTIES AND RESPONSIBILITIES
REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:
KNOWLEDGE, SKILLS AND ABILITIES:
