Department: Azzur San Francisco, LLC
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, cell and gene therapy and biotechnology industry.
- Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others.
- Understands the product and equipment lifecycle process.
- Draws insights from projects and supplemental research to help drive new continuous improvement in reliability and maintenance processes.
- Ensures consulting services are efficient, optimized, and client centric.
- Highly motivated and organized, solutions-oriented leader
- Curious and adaptable - can transform knowledge into actionable activities.
- Able to produce results in a fast paced, collaborative environment.
Essential Duties and Responsibilities
Personnel are always expected to live up to our core values 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.
- Support new equipment additions and facility expansion projects by managing the manufacturing design inputs and outputs.
- Develop conceptual process designs and the corresponding process flow diagrams and piping/instrumentation diagrams as required to support manufacturing equipment additions and improvements.
- Implement the appropriate Quality Management procedures related to the life cycle of the process and utility equipment. Typical QMS include design control, commissioning & qualification, risk management, change control, quality assurance, asset management and corrective/preventative action (CAPA).
- Author standard operating procedures for the operation and maintenance of manufacturing equipment as well as support utilities.
- Develop process equipment procurement specifications and data sheets based on approved design documents.
- Develop design documents for the process equipment in accordance with Good Engineering Practices.
- Prepare detailed bid evaluations for procurement of the process equipment and system construction packages.
- Review vendor equipment drawings and specifications and drive the system integration of the equipment control systems with enterprise level computerized systems.
- Review and comment on detailed design packages from A&E firms.
- Create mapping of the critical quality attributes against the process requirements and identify the critical process parameters.
- Perform PHA, FMEA, FMECA and other applicable risk assessments against the proposed process to determine acceptable control strategies.
- Generate system impact assessments and critical component assessments including system boundary maps.
- Lead multi-functional design reviews, identify gaps to the original design documents and update design documents as required to remediate gaps.
- Capable of preparing commissioning and qualification documents for process equipment and the associated manufacturing lines.
- Assist in writing and executing process validation documents.
- Support on-site installation and startup activities for process equipment including:
- Conduct field installation/verification against design drawings and construction packages.
- Supervise the installation of the process equipment.
- Coordinate vendor, general contractor, and subcontractors construction and startup activities.
- Coordinate and execute startup checklists.
- Evaluate and remediate change requests or field changes.
- Support the execution FAT and SAT protocols.
- Education: BS/BA degree required. An advanced degree in Chemical, Mechanical or Biomedical Engineering is a plus.
- 8-10 years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry. 5 years of direct process engineering experience is a plus.
- Experienced in the areas of Process Equipment Design, specifically with isolators, autoclaves, parts washers and fill-finish equipment. Demonstrates a soldi understanding of cleaning validation and sterilization.
- Excellent written and verbal communication skills; excellent technical writing skills.
- 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.
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages 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.