Senior Validation Engineer
Do What You Love
At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.
Azzur Group is looking for Senior Facility C&Q Engineer to join our growing team. Working with a multi-disciplinary team, the Sr. Facility C&Q Engineer ensures completion of project deliverables according to the established plan. In this hands-on role, the Engineer is the one of the key liaison between project stakeholders (client, company and direct reports), and will be responsible for the quality of work produced by their team. Experience with cGMP and FDA compliance is essential.
Essential Duties and Responsibilities
- Write technical documents associated with projects.
- Write engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV) for facility and utility systems.
- Perform (hands on) field execution of commissioning and/or validation documentation.
- Reviewing equipment lists, instrument lists, drawings, specifications, and submittals to ensure quality, accuracy, and completeness.
- Performing field walk downs to ensure installation meets design requirements.
- Identifying deficiencies during installation and commissioning and ensure correction in a timely manner.
- Actively participate in the mentoring, training of junior engineers and development of internal company policies and procedures.
- BS Engineering or related discipline.
- Minimum 8 years C&Q experience in facility and equipment C&Q in the pharmaceutical, medical device and/or biotechnology industry is required.
- Strong utility and facility commissioning, qualification and validation experience.
- Experience with FDA compliance and cGMP is required.
- Must be results oriented with several years of hands-on experience, familiar with industry concepts, practices, and procedures in a cGMP environment.
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
- Demonstrated experience managing others as well as fostering a team focused approach. The ideal candidate shall excel in the areas of communication, leadership, client loyalty, initiative, and business integrity.
- Excellent verbal, oral, and technical writing communication skills.
- Proficient in Microsoft Word, Excel, Power Point, Project and able to quickly learn new computer applications.
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.
No matter where you are in the product development lifecycle, Azzur is here to help you start, scale, and sustain your business. From pre-clinical manufacturing to process design and process performance qualification, Azzur Group works hand-in-hand with the world's most renowned manufactures to employ risk-based and phase appropriate GxP solutions.
With a national network of engineers and consultants, we offer comprehensive quality assurance and regulatory compliance, and validation services specifically geared for the complexities of life science.
Do What You Love
We are seeking highly motivated individuals that have the desire to learn, can adapt to the ever-changing life sciences field and are flexible to work on various projects throughout the Southern California region all while exuding Azzur’s core values: Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!
We aim to serve our clients, create a healthy and fun work environment, and assist with professional growth for everyone through customized career development plans. As a consultant working on multiple cross functional projects, you will be able to quickly garner a wide range of skills and areas of expertise that will propel your career progression.
If a clear career path forward and a positive, transparent, and fun company culture are something you are looking for in your next role, Azzur is the place for you!
Ideal QualitiesIdeal candidates will exhibit, or have the willingness to develop, the following qualities:
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results.
- Willing to work hands on with multiple clients
- Ensures activities are efficient, optimized, and client centric.
- Highly motivated and organized, solutions-oriented leader.
- Curious and adaptable - has the ability to transform knowledge into actionable activities.
- Able to produce results in a fast paced, collaborative environment.
Perks of Working at Azzur
- Medical, Dental and Vision
- Competitive 401K plan
- Flexible Paid Vacation Time
- Employee Recognition Program
- Diversity and Inclusion Initiatives
- Training and Mentorship Opportunities
Learn more about who we are and what makes us great here: https://www.youtube.com/watch?v=9VmKkBLkoFQ