Validation Engineer
WFA Digital Insight
The demand for skilled validation engineers in the biopharma industry has grown significantly, with a 25% increase in job openings over the past year. As the industry continues to evolve, professionals with expertise in validation protocols and quality performance are in high demand. Syner-G BioPharma Group, a leading biopharma product development and delivery partner, is seeking a talented Validation Engineer to drive overall quality performance and compliance. With a strong commitment to fostering a positive work environment and a reputation as one of the 'Best Places to Work,' Syner-G offers a unique opportunity for career growth and development. Before applying, candidates should be aware of the company's emphasis on innovation, leadership, and collaboration, as well as the need for strong technical skills and attention to detail.
Job Description
About the Role
The Validation Engineer role at Syner-G BioPharma Group is a critical position that requires a high level of technical expertise and attention to detail. As a key member of the team, the Validation Engineer will be responsible for developing and executing validation protocols for various types of processes, driving overall quality performance and compliance throughout the organization. The ideal candidate will have a strong background in validation engineering, with experience in generating and executing life cycle documentation, supporting validation activities, and writing technical documents.The role will involve working closely with cross-functional teams, including the Maintenance and Engineering departments, to support the resolution of regulatory observations or manufacturing site issues. The Validation Engineer will also be responsible for performing periodic reviews and requalification for temperature chambers and executing thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
Syner-G BioPharma Group is committed to fostering a positive and engaging work environment, with a strong emphasis on culture, career growth, and development opportunities. The company has been recognized as one of the 'Best Places to Work' for three consecutive years, and offers a range of benefits and perks to support the well-being and success of its employees.
What You Will Do
- Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes
- Support validation activities for Basecamp and client Tech Transfer projects
- Write, review, and revise technical documents, including SOPs, validation/verification master plans, and execution plans
- Perform P&ID Walkdowns and thermal mapping of temperature-controlled chambers, warehouses, and SIP processes
- Support the resolution of regulatory observations or manufacturing site issues
- Execute periodic reviews and requalification for temperature chambers
- Write reports to summarize validation/verification/commissioning activities
- Collaborate with cross-functional teams to drive overall quality performance and compliance
What We Are Looking For
- Bachelor's degree in a relevant field, such as engineering or life sciences
- Minimum 3-5 years of experience in validation engineering, preferably in the biopharma industry
- Strong technical skills, including experience with validation protocols and quality performance
- Excellent writing and communication skills, with the ability to write technical documents and reports
- Ability to work in a fast-paced environment and prioritize multiple tasks and projects
- Strong attention to detail and ability to maintain accurate records
- Experience with regulatory requirements and industry standards, such as FDA and GMP
Nice to Have
- Experience with Basecamp and client Tech Transfer projects
- Knowledge of temperature-controlled chambers, warehouses, and SIP processes
- Familiarity with P&ID Walkdowns and thermal mapping
- Certification in validation engineering or a related field
Benefits and Perks
- Competitive salary and benefits package
- Opportunity for career growth and development in a leading biopharma company
- Collaborative and dynamic work environment
- Recognition and reward programs
- Flexible working hours and remote work options
- Access to cutting-edge technology and resources
- Professional development and training opportunities
How to Stand Out
- Familiarize yourself with the company's products and services, as well as the biopharma industry as a whole, to demonstrate your interest and knowledge
- Tailor your resume and cover letter to the specific requirements of the Validation Engineer role, highlighting your technical skills and experience
- Prepare to discuss your experience with validation protocols and quality performance, as well as your ability to work in a fast-paced environment
- Be ready to provide specific examples of your writing and communication skills, including technical documents and reports
- Research the company's culture and values to understand their emphasis on innovation, leadership, and collaboration, and be prepared to discuss how you can contribute to these efforts
- Consider reaching out to current or former employees to gain insights into the company culture and work environment
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