Quality Engineer-OTC Personal Care

About SnugZ

SnugZ operates an FDA-registered manufacturing facility in West Jordan, Utah, where we manufacture, test, and release over-the-counter (OTC) drug and personal care products, including SPF lip balms, sunscreens, and hand sanitizers, under 21 CFR Parts 210 and 211. Our Quality Unit oversees these products from incoming materials through batch release and post-market complaint handling.

SnugZ is a private equity-backed company and a national supplier of branded consumer products, including drinkware, bags, and accessories, sold through a nationwide distributor network.

Position Summary

The Quality Engineer is a hands-on, floor-facing technical role in SnugZ's Quality Unit, reporting to the QA Manager. This person will bring engineering discipline to how our products are made: validating manufacturing and cleaning processes, qualifying equipment and utilities, strengthening production controls, and leading manufacturing investigations to real root causes.

SnugZ is carrying out a focused quality improvement program with commitments centered on manufacturing operations. The Quality Engineer will own key deliverables in that program and help make the improvements last.

Key Responsibilities

Primary responsibilities make up roughly 90% of the role; support responsibilities make up the remainder.

Validation and qualification

• Write, execute, and report process validation protocols (Stages 1–3) for OTC liquid, gel, and semi-solid products, including hand sanitizers, sunscreens, and SPF lip balms.

• Lead cleaning validation and the continued validation monitoring program (CVMP) for manufacturing and filling equipment.

• Qualify manufacturing and filling equipment and utilities (IQ/OQ/PQ), including the purified water system (reverse osmosis), and keep them in a validated state through calibration, preventive maintenance, and requalification.

• Maintain the validation master plan and the validation schedule.

Manufacturing operations and production controls

• Serve as the Quality Unit's technical presence on the production floor, observing batching, filling, and packaging operations and identifying gaps in process controls, equipment setup, and documentation practices.

• Define and verify critical process parameters and in-process controls, and translate validation results into clear master batch record and SOP requirements.

• Strengthen day-to-day production controls, including line clearance, equipment cleaning and status labeling, and batch record completion in line with good documentation practices (GDP/ALCOA+).

• Write and revise operational SOPs, train operators on new and revised procedures, and verify on the floor that training has been effective.

Investigations, CAPA, and change control

• Lead manufacturing deviation and complaint investigations using structured root cause tools (5 Whys, fishbone, fault tree), and define CAPAs with measurable effectiveness checks. Support OOS investigations when a manufacturing cause is suspected.

• Deliver assigned corrective actions on schedule, with clear, inspection-ready documentation and objective evidence.

• Assess changes to processes, equipment, materials, and facilities through change control, including validation impact and whether a change must be reported to FDA, and confirm required work is complete before implementation.

• Apply risk management (ICH Q9, FMEA) to processes and equipment to prioritize validation and control activities.

Support responsibilities

• Support trending of batch, purified water, environmental monitoring, and complaint data, and help establish statistical process control and capability studies for key parameters.

• Support the design of statistically sound sampling plans for retain sample testing and record reviews.

• Contribute to annual product reviews.

• Responsible for equipment gauge calibrations.

• Support supplier qualification and incoming material controls for raw materials, packaging, and components.

• Support FDA inspections and internal audits, and work with independent consultants and third-party laboratories as needed.

Qualifications

Required

• Bachelor's degree in Chemical, Industrial, or Biomedical Engineering, Microbiology, or a related technical field.

• 5+ years of quality engineering or validation experience in FDA-regulated cGMP manufacturing, including at least 3 years with OTC drug and/or personal care products (e.g., hand sanitizers, sunscreens, lip balms, lotions, topical products).

• Hands-on experience writing and executing process validation, cleaning validation, and equipment/utility qualification protocols.

• Demonstrated experience working directly with production teams on the manufacturing floor to improve process controls and operator practices.

• Working knowledge of 21 CFR Parts 210 and 211, OTC monograph requirements, and FDA guidance on process validation.

• Proven ability to lead root cause investigations and CAPAs to verified closure.

• Working knowledge of statistics (SPC, capability, sampling plans) and tools such as Minitab or JMP.

• Clear, precise technical writing.

Preferred

• Experience supporting a company through an FDA Form 483 or Warning Letter remediation.

• Experience with purified water systems (RO/DI) and microbiological controls for topical products, including objectionable organisms such as Burkholderia cepacia complex (BCC).

• Familiarity with 21 CFR Part 11 and data integrity expectations for production records.

• Familiarity with cosmetic regulations (MoCRA) and with products that are both a drug and a cosmetic.

• ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt.

• Bilingual English/Spanish.

Key Attributes

• Hands-on. Spends most of the week on the production floor and in the lab, not at a desk.

• Rigorous. Follows the data to root cause and documents work so it stands up to FDA review.

• Urgent and organized. Manages several protocols and investigations at once and meets commitments.

• Collaborative. Works well with operators, analysts, managers, and outside consultants.

Work Environment and Physical Requirements

• Work is performed primarily on-site in manufacturing, filling, packaging, warehouse, and laboratory areas, with the remainder in an office setting.

• Must follow gowning and PPE requirements in production and laboratory areas, such as safety glasses, gloves, hair and beard covers, and lab coats.

• Must be able to stand and walk for extended periods, reach and bend to access equipment, and occasionally lift up to 55 lbs.

• Work involves exposure to cleaning agents, alcohol-based and flammable materials, and moderate noise from manufacturing equipment.

• Occasional extended hours or schedule flexibility may be needed to support validation runs, production schedule, and project deadlines.

• Travel is minimal, such as visits to suppliers or contract laboratories.

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

What Success Looks Like

First 90 days

• Learn our products, processes, and quality system, and complete a review of the validation status of processes, cleaning, equipment, and water.

• Establish a regular presence on the production floor and working relationships with Operations leads.

• Take ownership of assigned corrective actions and validation protocols and execute them to the committed schedule.

First 12 months

• Assigned validation and corrective action commitments completed on schedule, with protocols and reports that hold up to FDA and consultant review.

• Manufacturing investigations and CAPAs reaching real root causes, with effectiveness checks in place.

• Measurable improvement in production controls and operator practices, such as fewer recurring deviations.

Snugzusa LLC is an equal opportunity employer and is a supporter of diversity and inclusion. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.