Associate R&D Process Engineer, Business Sustaining

Location - Vista, CA - On Site

Salary - 84K - 89K

POSITION SUMMARY

The Associate R&D Process Engineer, Business Sustaining, supports material, formula & process sustainment activities across softgel, gummy, and packaging operations, ensuring robust, compliant, and efficient manufacturing processes. This role assists in implementing material and process changes, executing engineering trials, maintaining process documentation, and supporting cross‑functional investigations. Working under the guidance of the Senior R&D Process Engineer, the Associate contributes to scale‑up readiness, process optimization, and documentation accuracy across Product Development, Operations, and QA.

The position is designed to grow into a full Process Engineer role, gaining increasing ownership of engineering trials, process improvements, and technical problem‑solving.

ESSENTIAL FUNCTIONS

Reasonable Accommodations Statement

To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.

Essential Function Statement(s):

Material Qualification & Implementation

• Support execution of material change projects across softgel, gummy, and packaging processes, ensuring compliance with cGMP and internal quality systems.
• Assist in drafting and maintaining change control documentation (change requests, qualification protocols, impact assessments, technical reports).
• Collaborate with Tech Ops, Manufacturing, QA, and PD Engineering to assess impacts and support material qualification activities.

Engineering Trials, Scale‑Up & Process Development

• Own small‑scale engineering trials for softgels, gummies, and packaging‑adjacent processes, including data collection and parameter tracking under guidance.
• Support packaging trials and assist in softgel and gummy process development (encapsulation, cooking, drying, finishing, sampling).
• Support DOE studies, center‑lining, process capability assessments, and troubleshooting of process deviations.

Process Documentation & Continuous Improvement

• Own updates to MMRs, SOPs, batch records, and work instructions; maintain documentation accuracy through change control processes.
• Support development of process flow diagrams, equipment specifications, and trial documentation.
• Own small process improvement initiatives and support RCA/CAPA investigations through data gathering, documentation, and analysis.

Cross‑Functional Collaboration & Operational Support

• Work closely with Operations Engineering, Maintenance, PD Formulators, Process & Packaging Engineers, QA, and Supply Chain to support business‑sustaining activities.
• Provide technical support during production runs, helping troubleshoot material, process, and documentation issues.

POSITION QUALIFICATIONS

• BS in chemical engineering, industrial engineering, pharmaceutical engineering, food science, or related field.
• Experience in manufacturing, process development, or engineering (internships acceptable). Experience with dietary supplements, food, pharmaceutical, or regulated manufacturing preferred.
• Familiarity with SAP, PLM, or other manufacturing systems is a plus.
• Hands‑on experience with production equipment, pilot trials, or lab‑scale process work preferred.
• Must be able to read, interpret and create documents such as standard operating procedures, batch records, specifications, test reports and regulatory guidelines.
• Ability to learn and operate specialized instrumentation for product characterization and specification development.
• Ability to deal with complex problems with many variables.

SKILLS & ABILITIES

• Meticulous attention to detail.
• Solution-focused.
• Ability to work in a dynamic environment and adapt to change.
• Ability to follow instructions to produce high-quality work with limited supervision.

Computer Skills:

• Must be proficient with MS Office or Google Suite and have advanced Excel skills.

Certifications & Licenses:

N/A

PHYSICAL DEMANDS

Physical Demands

Lift/Carry

Stand

F (Frequently)

Walk

F (Frequently)

Sit

F (Frequently)

Handling / Fingering

F (Frequently)

Reach Outward

O (Occasionally)

Reach Above Shoulder

N (Not Applicable)

Climb

N (Not Applicable)

Crawl

N (Not Applicable)

Squat or Kneel

O (Occasionally)

Bend

O (Occasionally)

10 lbs or less

F (Frequently)

11-20 lbs

O (Occasionally)

21-50 lbs

O (Occasionally)

51-100 lbs

N (Not Applicable)

Over 100 lbs

N (Not Applicable)

Push/Pull

12 lbs or less

O (Occasionally)

13-25 lbs

O (Occasionally)

26-40 lbs

O (Occasionally)

41-100 lbs

N (Not Applicable)

O (Occasionally)

Occupation requires this activity up to 33% of the time (0 - 2.5+ hrs/day)

C (Constantly)

Occupation requires this activity more than 66% of the time (5.5+ hrs/day)

Other Physical Requirements

Vision (Near, Distance)

Sense of Sound (ability to hear on the phone)