Engineering h1.location_city

Your role

The Engineering Manager will have a vast understanding of engineering, engineering management, manufacturing, quality assurance, product design and process development in pharmaceutical and medical device manufacturing and will be responsible for all technical engineering tasks for execution of new product development projects, and major CAPEX Site Project approval and execution.

Interacts closely with Project Management and MS&T teams for clinical and development projects to ensure the execution of projects are performed in a timely manner and on schedule.Ensures the Process Engineers provide updates and supporting information to Project Management to ensure project status and critical information is accurate and provided in a timely manner.

Will ensure technical and engineering proficiency of new product and material technical development, product efficacy and safety validation, biocompatibility testing, preparation of IDE, IND, PMA and NDA technical sections, initiating and developing new technical and product release process.

Must have very strong technical credentials and also have the ability to manage and develop the people and functions that are part of the Engineering department.The Engineering Manager must also work closely with other departments on site initiatives for facility, equipment acquisition, site modifications, and qualifications.

Responsibilities

• Interface with Project Management and MS&T teams to direct the execution of new products with the Process Engineers .
• Meet agreed upon budget and ensure compliance goals are met.
• Work closely with engineers executing development and clinical project execution in Manufacturing to provide guidance and assurance that project timelines are met.
• Work closely with Manufacturing, Materials and Quality Assurance to execute new customer development projects in the manufacturing system while meeting critical customer timelines and cost targets.
• Provide leadership and oversight his/her direct reports in the engineering team
• Provide technical support to Maintenance, Facilities and Calibration management.
• Lead major CAPEX process or equipment projects as required.Coordinate required qualifications and validations.
• Provide technical support to the manufacturing group as required.
• Fulfill responsibilities as a member of the DCR, Deviation and CAPA team.
• Identify potential manufacturing process or product improvements and implement efficient manufacturing methods to produce quality products.
• Oversee design and installation of production tooling and equipment. Direct launch of new products and processes at the production floor level execution.
• Provide technical support for evaluating and resolving CAPA’s.
• Responsible for department budgeting, equipment purchases, and project planning.
• Evaluates testing and manufacturing equipment in order to purchase or to make recommendations for purchase of equipment to be used in Manufacturing.
• Lead the engineering professionals on product development, process validation and design control.
• Stay abreast of current and newly emerging technologies to ensure that appropriate manufacturing techniques are utilized to manufacture high volume, high yield and high value products in aseptic operations.
• Any and all other duties as assigned by immediate supervisor.

Your profile

Required Knowledge, Skills and Abilities

• Ability to function well in a team environment.
• Requires extensive interfacing with manufacturers of equipment and vendors of diverse educational backgrounds.
• Must possess excellent oral and written communication skills.
• Must interface well cross functionally.
• Strong well-rounded engineering and project management experience.
• Superior analytical and computer skills.
• Capable of using good reason and judgment to make and defend recommendations.
• Proficient in computer skills, with Windows, Word, Excel, AutoCAD 14, Solid Works, Microsoft Project etc.

Required Education and Experience

• Bachelor of Science Degree in Engineering. Master's Degree preferred
• 10 years engineering experience in manufacturing/product development environment in medical/pharmaceutical or similar industries
• 3 or more years’ experience in managing an engineering team
• Experience in Aseptic Processing is an advantage
• Further preferred qualifications: PMP, MBA, Lean Six Sigma Green Belt

Working at Siegfried

Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.

Who we are

In the Midst of People’s Lives – Across the Globe The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model. The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production. We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.

What we do in Irvine

Irvine is one of Siegfried’s sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices.

Main activities

• Provides cGMP sterile drug product fill finish of biologics, suspensions, emulsions, ointments, and gels
• All fully cGMP and SHE compliant

Features

• Commercial Products: 5 automated filling lines, Commercial manufacturing, Batch sizes up to 150 K units, Fill Volumes 0.5 ml – 100 ml
• Semi-automated and automated visual inspection
• Automated packaging with digital data visual verification
• Stability study services
• Drug delivery
• Laboratory services
• Clinical Products small lot capability (semi-automated filling, batch sizes up to 5 K units)
• Clinical manufacturing (batch sizes less than 5 K units)

Strategic importance

• CDMO for innovative and difficult-to-manufacture products from clinical to commercial NDA and ANDA products
• Provides contract sterile drug product manufacturing and laboratory services to the pharmaceutical and biotechnology industries