Department: Azzur Consulting LLC
Expected Salary Range: $105,000-135,000
We're seeking a seasoned CQV Workstream Lead/Validation Manager with a solid 8 - 15 years of industry experience, ideally within the medical device, pharmaceutical, and biotechnology sectors. The ideal candidate should be comfortable in client-facing roles, managing small dynamic teams, and making high-level presentations. Our expectation is for a proactive individual who enjoys hands-on project management and technical execution and thrives in dynamic environments.
- Provide strategic direction and leadership to the team, guiding them through all technical aspects of the project lifecycle.
- Develop comprehensive project plans, define roles and responsibilities, and determine the scope of work in conjunction with key stakeholders.
- Understand, manage, and deliver on project requirements sourced from proposals, specifications, meetings, verbal direction, or other means.
- Write and revise engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV).
- Conduct field execution of commissioning and/or validation documentation.
- Ensure timely delivery of project requirements, adhering strictly to project schedules and budgets. Keep clients and management abreast of project status as necessary.
- Spearhead business development initiatives to secure additional projects and clientele.
- Engage in the mentoring and training of junior engineers and contribute to the development of company policies and procedures.
- Strategic and analytical thinker who can interpret client needs and translate them into actionable value-added projects/results.
- In-depth understanding of the competitive landscape within the medical device, pharmaceutical, and biotechnology industry.
- Willingness to engage in hands-on tasks, build client libraries, learn from mentors, and mentor others.
- Comprehensive knowledge of worldwide regulations and appropriate phase applications.
- Ability to glean insights from projects and supplemental research to drive new and existing growth.
- Efficiency-driven, client-centric mindset.
- Highly organized, motivated, solution-oriented leader.
- Naturally curious and adaptable, with a knack for converting knowledge into actionable activities.
- Ability to thrive and produce results in a fast-paced, collaborative environment.
- BS in Engineering or a related field.
- 8 - 15 years of project management experience in the pharmaceutical and/or biotechnology industry.
- Proficiency in project schedule applications such as Smartsheets, MS Project, other
- Experience with FDA compliance and cGMP.
- Hands-on experience with industry concepts, practices, and procedures in a cGMP environment.
- Experience in 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.).
- Proven ability to manage and foster a team-focused approach with outstanding communication, leadership, client loyalty, initiative, and business integrity.
- Excellent verbal, oral, and technical writing communication skills.
- Proficient in Microsoft Word, Excel, Power Point and able to quickly learn new computer applications.
Essential Duties and Responsibilities
Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.
- Lead, direct and develop company personnel through all technical aspects of the project lifecycle
- Develop project plans, define roles and responsibilities and the scope of work for each project with input from key stakeholders
- Understand and manage deliverables of all project requirements originating from the proposal, specifications, meetings, verbal direction, or other means
- Write engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV)
- Perform (hands on) field execution of commissioning and/or validation documentation
- Responsible for working with all team members to ensure timely delivery of project requirements (schedule, budgets, and costs). Ensure project team members work within the project schedule and budgets. Provide updates to client and management indicating status of project as required
- Perform business development work as necessary to procure additional work at their site as well as additional clients
- Actively participate in the mentoring, training of junior engineers and development of internal company policies and procedures
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
- BS Engineering or related discipline
- 3-5 years’ project management experience in the pharmaceutical and/or biotechnology industry is required
- Microsoft Project Experience is required
- 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 and able to quickly learn new computer applications
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.
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 is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:
Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!