Sr. Project Engineer
- Education: BS/MS degree required. An advanced degree in Chemical, Mechanical or Biomedical Engineering is a plus.
- 10-15 years’ experience in a regulated, manufacturing environment within the biotechnology or pharmaceutical industry.
- A minimum of 5 years of experience overseeing and implementing technical engineering projects is a requirement.
- Experience with facilities, utilities, and process equipment. Examples include vessels, tanks, centrifuges, filter press, clean in place (CIP) systems, air handling units (AHU), reverse osmosis (RO), compressed gases, cooling water, and waste systems.
- Develop and closeout change control documentation accommodating agreed changes to the design, in collaboration with the client Subject Matter Experts.
- Support development of conceptual process designs and the corresponding process flow diagrams and piping/instrumentation diagrams.
- Support development of design documents for the process equipment in accordance with Good Engineering Practice, i.e. URS, FRS, HDS, SDS, CS, etc.
- Experience in executing FMEAs, system impact assessments (SIAs), and other applicable risk assessments (RAs).
- Prepare detailed bid evaluations for procurement of the process equipment and system construction packages.
- Support development of process equipment procurement specifications and data sheets based on approved design documents.
- Manage and coordinate FATs and SATs.
- Experience overseeing the qualification of building automation systems (BAS) and control systems (Siemens/Desigo, Delta V control system).
- Manage all aspects of the Process Engineering function from concept to final qualification and system release, including project updates and maintaining process equipment project schedules.
- Review vendor equipment drawings and specifications and drive the system integration with the site utilities and computerized systems (SCADA).
Ideal Project Leadership Qualities:
- Prior experience leading facility expansion projects, facility buildouts, and/or process development.
- Provide technical leadership in deviation, out-of-specification, and change control management, ensuring compliance with internal standards and regulatory requirements.
- Run technical meetings, develop action lists, and drive actions to completion.
- Project planning and scheduling for Commissioning, Qualification, and Validation.
- Progress measurement and reporting for Commissioning, Verification, and Validation.
- Highly motivated and organized, solutions-oriented leader.
- Able to produce results in a fast paced, collaborative environment.
- Excellent facilitation, negotiation, conflict resolution skills, and cross functional collaboration skills to foster positive business relationships with the ability to network with different functional areas.
- Excellent written and verbal communication skills; excellent technical writing skills.
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results.
- Strong interpersonal skills and the ability to work in a team environment.
- Ability to work effectively in a fast-paced multitasking environment.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.
- Working for multiple clients throughout the region.
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.
Perks of Working at Azzur
- Medical, Dental and Vision
- Competitive 401K plan
- Wellness reimbursement program
- Volunteer Paid Time Off
- Flexible Paid Vacation Time
- Employee Recognition Program
- Diversity and Inclusion Initiatives
- Training and Mentorship Opportunities