Department: Azzur Consulting LLC
Expected Salary Range: $72,000 to $110,000
Essential Duties and Responsibilities:
- Generates and executes life cycle documentation (FAT, SAT, CTP, DQ, IOQ, PQ) for facilities, utilities, manufacturing/lab equipment (cell culture, protein purification, cell and gene therapy, fill-finish) computer systems, automation, and processes (cleaning, sterilization, shipping) for qualification/requalification.
- Reviews, advises on, and contributes to change control documents. Provides sound validation/verification assessments.
- Writes, reviews and revises a variety of Commissioning and Qualification protocol related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design review, commissioning, qualification or other technical documents such as user requirement specifications (URS), System Classification, System Risk Assessments, functional requirement specifications (FRS), detailed design specifications and/or commissioning test procedures.
- Writes summary reports to summarize Commissioning and Qualification testing.
- Writes procedures, investigations, change controls, etc. to support the validation lifecycle documentation.
- Develops and executes validation plans and protocols for Process Performance Qualification (PPQ), mixing validation, L&E, materials qualification and other manufacturing processes.
- Work with contractors and equipment vendors, as necessary, to ensure validation packages are provided and completed to the required standards, on schedule.
- Work independently to collect, organize and evaluate validation data and review work of other engineers in the team. Keep validation management informed about the progress and any obstacles.
- Initiates and performs investigations to close out protocol discrepancies and deviations. Ensures corrective actions are resolved in a timely manner. Supports the resolution of regulatory observations or manufacturing site issues.
- Performs P&ID Walkdowns, installation and operational tests for equipment and utilities. Performs Thermal mapping of temperature-controlled chambers, (refrigerator, freezers, incubators, cryo storage) warehouses, and SIP processes.
- Provides assistance with project management for mid to complex size projects for commissioning, qualification of new engineering systems and facilities.
- Collaborates well with the cross-functional team and work efficiently in a team environment. Communicates effectively with management, stakeholders, regulatory agencies and vendors. Assists in providing training to other engineers in the team.
- Bachelor’s or Master's Degree in engineering, science, or equivalent technical degree.
- 2-6 years’ experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, cell and gene or medical device industry.
- Hands on experience in executing C&Q protocols for facilities, utilities and manufacturing/lab equipment and processes. Experience with cycle development for cleaning and sterilization, automation/CSV and temperature mapping
- Experience in Quality or QAV is desired.
- Strong knowledge of FDA, EU and cGMP regulations and good documentation practices.
- Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams.
- Proficient in Microsoft Word, Excel, Project, and PowerPoint
- Strong interpersonal skills and the ability to work in a team environment with attention to detail.
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.
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 5 core values; Integrity, 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.