Cleaning Validation SME Job Indiana Borough area,Pennsylvania USA,Quality Assurance

Cleaning Validation SME Business Unit:
Global Quality & Compliance Job Grade:
Senior Manager

Location:

Tandalja, Vadodara Key Responsibilities

Lead and manage Cleaning Validation activities for sterile and non-sterile manufacturing facilities.

Prepare, review, and approve cleaning validation protocols, reports, and master plans (CVMP).

Act as Subject Matter Expert (SME) for cleaning validation across the site.

Establish acceptable limits (MACO/PDE) and perform risk assessments for cleaning processes.

Ensure compliance with global regulatory guidelines (USFDA, EU GMP, WHO, MHRA).

Drive execution, monitoring, and lifecycle management of cleaning validation programs.

Collaborate with Quality Assurance, Production, QC, Engineering, and Regulatory teams.

Participate in and support regulatory inspections and audits, addressing observations effectively.

Investigate cleaning failures/deviations and implement CAPA.

Ensure alignment of cleaning validation with production operations and campaign management.

Optimize cleaning processes to improve efficiency without compromising compliance.

Manage change control, revalidation, and periodic review activities.

Manage cross-functional teams and projects.

Ensure strong adherence to data integrity (ALCOA+) and documentation practices.

Travel Estimate

Minimal to moderate travel (as per project, audit, or site requirements)

Job Requirements Educational Qualification

Bachelors / Masters Degree in Pharmacy, Chemistry, Chemical Engineering, or related field

Experience

Tenure:
Minimum 12 years

Minimum 8+ years of hands‑on experience in Cleaning Validation activities

Strong background in Quality Assurance

Mandatory experience in sterile and non-sterile pharmaceutical operations

Good understanding of production processes and equipment cleaning practices

Proven experience in handling regulatory audits/inspections

Demonstrated ability to manage cross‑functional teams and stakeholder

Good in communication

EEO Statement

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Disclaimer

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

#J-18808-Ljbffr