Operations GMP Cleaning Specialist

Piramal Pharma Limited; Northern (KY); Hybrid; USD 42,000 - 65,000; Full time

Job summary

Piramal Pharma Solutions is seeking an Operations GMP Cleaning Specialist to support manufacturing by maintaining cleanliness of production areas, cleanrooms and equipment in accordance with GMP and GDP principles. You'll execute cleaning and sanitation activities, document accurately, and help maintain inspection readiness.

Preferred candidates have a high school diploma and 0–1 years in pharma or regulated-cleaning environments; entry-level candidates encouraged to apply and learn on the job.

Qualifications

• High school diploma or GED required; equivalent combinations considered.
• Experience in pharmaceutical or regulated cleaning is preferred but not required.
• Ability to follow SOPs, GDP/ALCOA principles and maintain accurate documentation.

Responsibilities

• Perform cleaning and sanitation activities per SOPs and validated procedures.
• Document line clearance before and after cleaning operations.
• Maintain status labels on equipment and areas (Cleaned, To Be Cleaned, In Use).
• Prepare cleaning solutions per approved concentrations and expiry requirements.
• Support cleaning validation, swab and rinse sampling activities.
• Complete documentation in accordance with GDP/ALCOA; assist with deviations and investigations.
• Adhere to contamination control procedures and proper PPE usage.
• Maintain readiness for inspections and assist internal/external audits.
• Replenish cleaning supplies and ensure safe, compliant work environment.

Skills

Cleaning procedures

GMP compliance

Documentation (GDP/ALCOA)

Safety protocols

Equipment handling

Education

High School Diploma or GED

Job description

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com

Operations GMP Cleaning Specialist

Piramal Pharma Solutions (Sellersville, PA) is seeking an Operations GMP Cleaning Specialist to support manufacturing operations by maintaining the cleanliness and organization of production areas, cleanrooms, equipment and facility spaces in accordance with GMP requirements, company procedures, safety standards and regulatory expectations. The Operations GMP Cleaning Specialist will execute cleaning and sanitation activities, maintain accurate documentation, support contamination control practices and ensure operational areas remain inspection‑ready. This position may also support inventory replenishment of cleaning supplies and materials to maintain a safe and compliant work environment. Occasional evening and weekend work may be required to support business needs.

Essential Duties and Responsibilities

• Perform cleaning and sanitation activities in accordance with approved SOPs and validated cleaning procedures.
• Conduct and document line clearance activities before and after cleaning operations.
• Maintain equipment and area status labels (e.g., Cleaned, To Be Cleaned, In Use).
• Prepare, label, and manage cleaning solutions according to approved concentrations, contact times, and expiration requirements.
• Execute cleaning activities in compliance with cleaning validation requirements and support swab and rinse sampling activities.
• Complete all documentation in accordance with Good Documentation Practices (GDP) and ALCOA principles.
• Initiate and support deviations, investigations, and corrective actions related to cleaning or documentation issues.
• Follow contamination control procedures, including proper segregation of equipment and materials.
• Adhere to cleanroom behaviors, gowning requirements, and approved cleaning techniques.
• Maintain inspection and audit readiness and support internal and external audits as required.
• Replenish and maintain cleaning supplies and operational consumables.
• Follow all safety policies, procedures and PPE requirements.
• Perform other duties as assigned.

Education and Experience

• High School Diploma or GED required.
• Equivalent combinations of education, training and experience will be considered.
• Preferred 0‑1 years of commercial, industrial, pharmaceutical, GMP or regulated-environment cleaning experience preferred.
• Experience working in a manufacturing, pharmaceutical or cleanroom environment is a plus.
• Entry‑level candidates with a strong work ethic and willingness to learn are encouraged to apply.

Physical Requirements

• Ability to lift up to 40 pounds.
• Ability to occasionally move drums weighing up to 300 pounds using appropriate equipment and safe work practices.
• Ability to stand, walk, bend, stoop, reach and perform repetitive movements for extended periods.
• Ability to safely work around manufacturing equipment and cleaning chemicals.
• Must be able to wear required Personal Protective Equipment (PPE).
• Must not have allergies to chemicals or biological substances commonly found in manufacturing environments.

Travel Requirements

No regular travel required.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the-counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.