Control Systems Project Manager

Location: San Diego Consulting
Department: Azzur San Diego, LLC

Job Description

Basic Qualifications & Position Requirements: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.)

Required Education:

·       Bachelors Degree in engineering, science, or equivalent technical degree

Preferred Education:

·       Masters Degree in engineering, science, or equivalent technical degree

·       PMP Certification

Required Work Experience: 

·       15+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry

·       Demonstrated Project management experience for pharmaceutical and biotechnology projects.

·       Experience in developing and executing validation lifecycle documents for facilities and related systems. (e.g. DeltaV)

·       Experience using quality systems including deviation/investigation, CAPA and change control

Preferred experience:

·       Cell and Gene Therapy facilities and equipment validation experience

·       Control systems experience (e.g PLC, MES, BAS/BMS)

·       Experience in manufacturing process development and tech transfer

·       Experience in risk management techniques (e.g. FMEA, HAZOP, FTA)

Required Knowledge:

·       Strong knowledge of FDA and cGMP regulations and documentation practices

·       Strong knowledge of facility and control systems

·       Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form

·       Ability to read and interpret construction drawings, Piping and Instrument Diagrams (P&IDs), and electrical diagrams

Preferred Knowledge:

·       Knowledge of key principles of ICH Q10

·       Basic knowledge of ISO 13485

·       Knowledge of manufacturing processes (e.g. upstream manufacturing, downstream manufacturing, formulation, aseptic filling, tableting, packaging and labeling)

Essential Duties and Responsibilities:

·       Leads projects related to implementation of control systems

·       Writes procedures, investigations, protocols, reports change controls, etc. for cleaning, shipping, facilities, utilities, systems, equipment and processes.

·       Generates and executes life cycle documentation (Plans, URS, FRS, FAT, SAT, Protocols, Reports) for facilities, utilities, systems, equipment, cleaning, shipping and/orprocesses.

Skills:

·       Mathematical Skills including statistical analysis

·       Computer Skills including Microsoft Word, Excel and PowerPoint

·       Project Management skills

Additional Qualifications:

·       Customer service/client relations

·       Communication proficiency

·       Attention to detail

·       Can work productively independently with minor supervision

·       Self-motivated, flexible, dependable and available

·       Excellent organizational and time management skills



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