FDA-Regulated Facilities Hygiene Program Manager

Medical Products Laboratories | Philadelphia, PA

Imagine this: An auditor is arriving in two hours. Production has a changeover at noon. A new hire needs coaching on GDP. You’ve got this—because you run a disciplined, documented, and audit-ready sanitation program that keeps our packaging, manufacturing, and warehouse operations compliant and on schedule.

The mission

Build and sustain a best-in-class sanitation program that meets cGMP and SOP requirements, protects product quality, and supports flawless inspections—while developing a high-performing team.

Role basics

• Department: Operations
• Reports to: VP Operations
• Schedule: Primarily 1st shift (7:00am–3:30pm) with occasional 2nd shift presence; Full-Time, Non-Exempt
• Annual pay range: $60,000–$70,000, DOE

**FLSA Status: **Non-Exempt (Supervisory)

How you’ll make an impact

• Lead, schedule, and direct sanitation technicians across production, packaging, warehouse, and common areas.
• Ensure every cleaning task aligns with cGMP, FDA expectations, and internal SOPs—with impeccable GDP.
• Train and onboard staff; set standards, coach performance, and administer corrective actions when necessary.
• Own pre-op checks, routine inspections, and release areas for start-up.
• Manage the inventory, storage, and safe usage of approved chemicals/equipment; uphold SDS and labeling requirements.
• Champion audit readiness; support internal audits, customer visits, and FDA inspections.
• Investigate sanitation-related deviations and complaints; contribute to root cause analysis and CAPA effectiveness.
• Coordinate with QA and Production to align cleaning with changeovers and reduce downtime.
• Maintain and improve SOPs, validation protocols, and the master sanitation schedule in partnership with Quality.
• Oversee purchasing and tracking of sanitation supplies and equipment; manage the related budget.
• Drive OSHA compliance and enforce hygiene, gowning, PPE, and safety requirements.
• Take on additional duties as directed by Operations or Quality leadership.

Leadership & team

Direct supervision of cleaning technicians, including recommending hires, scheduling, work assignment, performance reviews, and issue resolution per company policy.

Qualifications you’ll need

• High school diploma or equivalent required; associate’s or technical credential preferred.
• 5+ years in GMP-regulated sanitation/cleaning/facilities within pharma, medical device, or other FDA-regulated manufacturing, with proven leadership responsibility.
• Knowledge of cGMP, FDA regulations (21 CFR 210/211 or 820), sanitation standards, master sanitation schedules, and cleaning validation.
• Strong communicator with audit-facing confidence.
• Proficiency with Microsoft Office, e-logbooks, or CMMS.
• Expertise in chemical handling, storage, disposal, and SDS protocols.
• Bilingual (English/Spanish or English/Hindi) preferred but not required.

Physical & work environment

• Frequent standing, walking, bending, kneeling, and reaching.
• Lift and carry up to 50 lbs.; push/pull equipment and carts.
• Manufacturing/warehouse setting with variable temperatures, noise, and chemical exposure.
• Consistent use and enforcement of PPE and GMP gowning.
• Primarily 1st shift with occasional off-shift flexibility for audits or urgent sanitation needs.

Rewards & growth

• Competitive hourly pay: $22.00–$28.00/hour, commensurate with experience.
• Medical, dental, and vision coverage.
• Paid time off plus company-observed holidays.
• 401(k) with company match (if applicable).
• Advancement opportunities within a stable, GMP-regulated organization.

Note: This job description reflects general duties and requirements for this role and is not intended to be an exhaustive list of all responsibilities. Duties, responsibilities, and activities may change, or new ones may be assigned, at any time with or without notice.

Core proficiencies

• Standard Operating Procedures (SOPs)
• Supervisory Experience
• Industrial Cleaning Equipment Operation

Equal Employment Opportunity

Medical Products Laboratories is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other status protected by applicable federal, state, or local law.