Sr CQV Consultant/ Project Manager

Responsibilities:

Important: Critically think about a holistic approach to Facility, Utilities, and Process Engineering activities

• Development of life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes.
• Development of a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
• Development of legacy procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments
• Provides client team members with basic understanding of regulatory and manufacturing requirements.
• Ability to generate templates and legacy documents for life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment and processes.
• Development of a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
• Development of legacy procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments
• Provides client team members with basic understanding of regulatory and manufacturing requirements

Qualifications

• BS in Engineering, Science, or equivalent technical degree.
• Must have 2+ years experience project supervision/management 
• 5+ years’ experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
• Experience in writing and executing protocols including systems such as process validation, utilities, manufacturing equipment
• Working knowledge of FDA and cGMP regulations and documentation practices
• Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams
• Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Proficient in Microsoft Word, Excel, and PowerPoint
• Mathematical Skills, Computer Skills including Microsoft Word and Excel, Statistical analysis skills

Perks of Working at Azzur

• Medical, Dental and Vision
• Competitive 401K plan
• Volunteer Paid Time Off
• Flexible Paid Vacation Time
• Employee Recognition Program
• Diversity and Inclusion Initiatives
• Training and Mentorship Opportunities

Do What You Love

At Azzur Group, it is our purpose to foster a culture that attracts and enables individuals with unique abilities and passions to reach both their life and career goals.  We take crucial steps to ensure that each employee is fulfilled both in and out of the office.

In addition to our purpose, we have a set of core values that we live and breathe each day. Every benefit offered here at Azzur is designed to uphold our 4 core values; Putting Others First, Having the Courage to Take Action, Taking Personal Responsibility and Having Fun. 

It is our mission to serve our communities, build positive and established relationships, create a healthy and fun work environment, ensure each employee and their families are healthy and thriving, grow each employee professionally with one of our customized training programs and keep a clear and open line of communication.

We are an equal opportunity employer and promote diverse culture, ethnicity, gender and age in our workplace. We believe that promoting diversity plays an important role in developing top quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.

If philanthropy, long lasting relationships, 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 Qualities:

Ideal 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
• Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry
• Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others. 
• Understands worldwide regulations and phase appropriate applications
• Draws insights from projects and supplemental research to help drive new and existing growth. 
• 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