Sr Development Engineer I

SK pharmteco Inc.; Rancho Cordova (CA); On-site; USD 130,000 - 180,000; Full time

Job summary

SK pharmteco Inc. seeks a Senior Development Engineer to lead development and scale-up of chemical manufacturing processes from development through initial plant implementation.

You will translate development into manufacturing-ready operations, identify scale-up risks, and provide technical leadership for successful first-time plant execution while collaborating with Chemistry, Analytical, Operations, Facilities, Quality, and Safety teams.

Qualifications

• Bachelor's degree in Chemical Engineering or related field is required.
• Experience with process development, scale-up, and GMP/documentation is expected.
• Strong safety mindset and ability to work cross-functionally across departments.

Responsibilities

• Lead development and scale-up of chemical manufacturing processes.
• Identify scale-up risks, gaps in processes/equipment, and develop technical strategies.
• Develop GMP documentation, batch records, work instructions, and change controls.
• Provide technical leadership for first-time plant execution and support manufacturing campaigns.
• Lead technical calls and cross-functional teams to resolve process issues.
• Mentor junior engineers and ensure adherence to safety policies.

Skills

Process development

Scale-up

Cross-functional collab

Safety compliance

Education

Bachelor's degree in Chemical Engineering

Master's degree in Chemical Engineering or related

PhD in related field

Job description

Job Summary

The Senior Development Engineer is responsible for leading the development and scale-up of chemical manufacturing processes during familiarization, development, and initial plant implementation. This advanced position translates development processes into manufacturing-ready operations, identifies key scale-up risks and process or equipment gaps, and provides technical leadership for successful first-time plant execution. The engineer collaborates cross-functionally across Chemistry, Analytical, Operations, Facilities, Quality, Safety, and other functions and provides subject matter expertise and training within the organization.

Job Summary

The Senior Development Engineer is responsible for leading the development and scale-up of chemical manufacturing processes during familiarization, development, and initial plant implementation. This advanced position translates development processes into manufacturing-ready operations, identifies key scale-up risks and process or equipment gaps, and provides technical leadership for successful first-time plant execution. The engineer collaborates cross-functionally across Chemistry, Analytical, Operations, Facilities, Quality, Safety, and other functions and provides subject matter expertise and training within the organization.

This work includes, but is not limited to, process development, scale-up, mass balances, process modeling, process and equipment gap assessment, manufacturing documentation, emission calculations, troubleshooting, investigations, and evaluation of new technologies. Works under consultative direction and assignments are often self-initiated.

Duties And Responsibilities

• Demonstrates broad application of engineering technical principles, theories, and concepts. General knowledge of other disciplines.
• Follows listed PPE requirements and chemical handling requirements, addresses safety issues promptly, and communicates safety issues to fellow employees.
• Leads complex process development and scale-up activities and applies strong organizational and planning skills.
• Identifies and evaluates key scale-up risks, process uncertainties, and process or equipment gaps and develops technical strategies to address them.
• Uses process modeling and engineering tools to characterize unit operations and support development decisions.
• Leads technical support for first-time scale-up and initial manufacturing campaigns, including preparation, execution, troubleshooting, and resolution of process issues.
• Takes the lead in development of GMP documentation, batch records, work instructions, variance responses, and change controls associated with development and scale-up activities.
• Works with process scientists and other technical functions to conduct and document scale-up and development activities.
• Evaluates process and equipment requirements and works with Operations, Facilities, and other engineering functions to close identified gaps for plant implementation.
• Can lead customer technical calls and Integrated Team Meetings and represents the company professionally in technical interactions.
• Provides leadership and training for junior engineers and other technical staff in Development Engineering and Operations.
• Anticipates potential safety issues and proactively incorporates safe solutions into development and scale-up strategies.
• Supports development investigations, root-cause analysis, and resolution of process or equipment problems and contributes to implementation of new technologies.
• Provides technical input to future manufacturing solutions and development strategies based on engineering experience.
• Adhere to all company SHE policies and procedures, actively participate in hazard identification and environmental risk reduction, and report all incidents, nonconformities, and potential hazards to management to support a safe, healthy, and environmentally responsible workplace.
• May perform other duties as assigned.

Education And Experience

• Typical requires 10-13 years of related experience and a bachelor's degree or 8-11 years of related experience and a master's degree or 5-8 years of related experience and a PhD in a related field.
• Bachelor's degree in Chemical Engineering, Chemistry, or a related engineering/scientific discipline, or equivalent combination of education and relevant experience required.

Competencies/Skills

• Strong interpersonal, verbal, and technical communication skills
• Must have a high consciousness for personal and laboratory safety
• Strong attention to detail, organization, and planning
• Team oriented and effective in cross-functional environments
• Highly motivated and willing to take initiative
• High mechanical aptitude and strong engineering judgment
• Knowledge of process development, unit operations, scale-up, and process optimization required
• Knowledge of process modeling, engineering calculations, or data analysis preferred
• Knowledge of cGMP manufacturing required.

CERTIFICATION/LICENSES

• Not applicable

WORKING CONDITIONS

On-site laboratory, office and pilot plant. Shift coverage (day, swing, night) will be periodically required. Periodically participates in production support that may include nights, weekends, and holidays.

This role may involve work in laboratory or manufacturing environments with potential exposure to chemicals or other regulated substances. As a condition of employment, incumbents may be required to participate in employer-provided medical surveillance programs in accordance with applicable regulatory requirements and company policy.

PHYSICAL CONDITIONS

Must be able to lift 25 lbs.