Associate Manager - Validation - MSAT

Use Your Power for Purpose

As a Senior Associate, you will play a crucial role in improving patients' lives while working at Pfizer. Your contributions will directly impact the development and delivery of innovative solutions that enhance the quality of life for patients worldwide. Join us in our mission to bring breakthroughs that change patients' lives.

What You Will Achieve

In this role, you will:

• Manage your own time to meet targets and develop plans for short-term work activities on moderately complex projects.
• Make decisions to resolve moderately complex problems in standard situations, working within guidelines and policies.
• Use your judgment to modify methods and techniques as needed.
• Collaborate with cross-functional teams to ensure project milestones are met.
• Provide technical support and expertise in the development and implementation of new processes and technologies.

Here Is What You Need (Minimum Requirements)

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience .
• Strong technical skills in process development and optimization
• Proficiency in data analysis and interpretation
• Experience with project management tools and methodologies
• Knowledge of regulatory requirements and compliance standards
• Ability to work collaboratively in a team environment
• Strong communication skills, both written and verbal
• Proficiency in Microsoft Office Suite

Bonus Points If You Have (Preferred Requirements)

• Experience in the pharmaceutical or biotechnology industry
• Familiarity with Good Manufacturing Practices (GMP)
• Experience with statistical software (e.g., Minitab, JMP)
• Ability to lead cross-functional teams
• Strong organizational skills
• Adaptability and flexibility in a dynamic work environment
• Ability to mentor and develop junior team members

Preferred Education/ Qualification: B.Pharm / M.Pharm /M.S (Pharmacy)/ M.Sc / BE

Experience: 5+ years of experience in Quality assurance and /or Validation function of sterile dosage form facility.

Core Competencies:

• Understanding of pharmaceutical manufacturing, packaging, quality assurance, and quality control operations.
• Knowledge of validation principles and practices related to the following areas: manufacturing process, analytical method, cleaning methods, facility, equipment, instrument, utility system, and CSV systems.
• Conversant with design & working principles of key equipment used in sterile manufacturing –Autoclave, Vial washing, Heat tunnel, Homogenizers, Vail filling, Filter integrity testing devices, Visual inspection equipment, Packing equipment, and Cleaning Validations.
• Well versed with Terminal process – design, execution and review.
• Experience in plant and TS operations.
• Good document review skills, data analysis with ability to identify issues and recommend actions
• Knowledge on the Qualification instruments and Tools.
• Knowledge on the GAMP requirements, PDA guidance, ISO guideline, 21 CFR part 11.
• Knowledge on the Components level assessment, PM requirement.
• Good knowledge on the Validation instruments calibration.
• Knowledge on the assessment of the Change controls and failure investigations. 
• Knowledge of current validation regulations in the industry and validation principles.
• cGMPs and FDA regulatory guidelines.
• Strong Technical skills, leadership, organizational planning and project management skills, in addition to strong technical background required to coordinate multi-disciplinary teams.
• Strong interpersonal skills.
• Excellent interpersonal effectiveness and communication skills (written and oral) to interface across departments and management levels.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.