Quality Engineer-OTC Personal Care

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.

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.

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

• 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.

• 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.

• 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 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.
• Re…