Lead the Way in Pharma Project Support – Become Our Project Support Specialist Manager at PDS Tech Commercial!

Position Overview: Are you a seasoned professional in process validation with a passion for ensuring compliance and quality in the pharmaceutical industry? PDS Tech Commercial is seeking a Project Support Specialist Manager to lead and execute key validation processes. In this vital role, you will coordinate the qualification of critical systems, oversee validation activities, and manage ongoing process verification to ensure that we meet corporate and global regulatory standards. If you have a strong background in validation, project management, and cross-functional collaboration, this is the opportunity for you!

Key Responsibilities:

• Validation Planning & Execution: Support and coordinate project validation activities, including vaporized hydrogen peroxide qualification of isolators, airflow visualization studies, packaging process validations, and shipping validation. Ensure all activities comply with corporate and global regulatory expectations.

• Process Validation Lifecycle: Maintain a state of control through ongoing process verification (OPV) and contribute to quality risk management by identifying key variables for monitoring. Author and review process, packaging, and process validation protocols and reports.

• Compliance & Documentation: Review Master Batch Records, change controls, and revalidation needs based on technical changes. Maintain activities under your responsibility in an inspection-ready status, ensuring compliance with cGMP and Company requirements.

• Risk Management & Technical Expertise: Lead pre-validation risk assessments and collaborate cross-functionally to ensure process risks are effectively controlled and documented. Manage deviations during process validation, recommending resolutions and prevention strategies.

• Launch & Transfer Support: Work closely with development teams and sending sites for technical transfers and new product launches, ensuring validation readiness and that all commercial processes meet validation requirements.

• Cross-Functional Collaboration: Coordinate with stakeholders to ensure validation milestones are met, processes are validated according to plan, and launches are implemented on target without preventable validation-related issues.

Key Performance Indicators:

• Achieving validation milestones within project timelines.

• Successful execution of validation protocols and reports on schedule.

• Compliance with global regulatory expectations, reflected in audit and inspection outcomes.

• On-time launches without preventable validation-related issues.

• Alignment with Company QM requirements and health authority standards.

Required Qualifications:

• Education: Bachelor’s degree in Chemistry, Pharmacy, Chemical Engineering, or Pharmaceutical Technology.

• Experience: 4-5 years in manufacturing, manufacturing science and technology, technical development, or quality, with specific expertise in process validation.

• Skills & Knowledge:

• Strong understanding of pharmaceutical manufacturing processes and related equipment.

• Expertise in writing and reviewing technical reports.

• In-depth knowledge of quality systems and regulatory requirements across various health authorities.

• Proven project management experience in cross-functional environments.

• Autonomous worker with a proactive approach to validation and compliance.

Preferred Qualifications:

• Experience executing process validation in a pharmaceutical setting.

• Fundamental understanding of pharmaceutical analytical testing and validation methodologies.

Ready to Lead and Drive Success in Pharma? If you’re a highly motivated professional with a strong background in validation, project management, and process compliance, apply today to join PDS Tech Commercial as our next Project Support Specialist Manager ! Your expertise can make a difference.

Apply Now!

Pay Details: $28.28 to $34.77 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.pdstech.com/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act

• Los Angeles City Fair Chance Ordinance

• Los Angeles County Fair Chance Ordinance for Employers

• San Francisco Fair Chance Ordinance