Validation Project Manager

ZipRecruiter; Philadelphia (Philadelphia County); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player in the life sciences sector is seeking a Validation Project Manager to join their dynamic team. This role offers a unique opportunity to lead CQV projects, manage vendor relationships, and ensure compliance with regulatory standards. With a commitment to professional growth and a collaborative environment, the company provides essential services that contribute to healthcare advancements. If you're passionate about making a difference and possess the necessary experience, this role could be your next career step.

Benefits

Medical Benefits

Sick Time Benefits

Qualifications

• 10+ years of CQV experience in a regulated GMP environment.
• Strong knowledge of regulatory standards (FDA, EMA, ICH).

Responsibilities

• Oversee CQV projects, manage vendors, and ensure compliance.
• Drive project success by assessing priorities, schedules, and budgets.

Skills

CQV Experience

Project Management

Regulatory Standards Knowledge

Risk Assessment Methods

Communication Skills

Education

Bachelor’s Degree in Engineering

Job description

PSC Biotech provides essential services to the life sciences industry, ensuring that healthcare products are developed, manufactured, and distributed in compliance with all regulatory requirements.

Our goal is to accelerate our clients’ success. We employ a global team of skilled professionals across North America, Europe, Asia, and the Middle East, and are proud of our contributions to our clients' achievements.

The Experience

With operations worldwide and a multicultural team, PSC Biotech is committed to bringing together talented individuals to create a dynamic and inspiring workplace. Joining our team offers opportunities for career growth, professional development, and collaboration with passionate colleagues.

We believe in coaching and developing future industry leaders. We offer competitive compensation, benefits, and tools to support your growth and learning. At PSC Biotech, we focus on your career and future, not just a job.

Your Role

We are currently accepting applications for future opportunities. By applying now, you join our talent pool for upcoming openings. This role is a W2-temp position for 6 months with potential extension to full-time employment. We seek an experienced Validation Project Manager to oversee CQV projects, manage vendors, and review technical execution, ensuring project success in compliance with industry standards and regulations.

• Drive project success by assessing priorities, schedules, budgets, and resolving risks and issues.
• Assist in developing CQV project plans aligned with design documentation and equipment specifications.
• Define scope of work for systems, including loop checks and hardware check-outs.
• Manage development of user requirements documentation per system.
• Collaborate with technical teams, contractors, and vendors to define system boundaries and lists.
• Coordinate instrument and equipment checkout activities.
• Oversee calibration activities with instrumentation contractors.
• Act as liaison between vendors and contractors for hand-offs.
• Review vendor contracts, timesheets, scope changes, and project scope.
• Support proposal writing for contracting and CQV resources.
• Maintain effective communication with stakeholders and project managers regarding progress, risks, and changes.
• Escalate potential risks or delays to upper management.
• Ensure documentation compliance with regulatory and quality standards.
• Lead project meetings as needed.

Requirements

• Bachelor’s degree in engineering or related technical field.
• 10+ years of CQV experience in a regulated GMP environment.
• Experience with facility build-out and project planning.
• Proven ability to manage equipment and instrumentation vendors.
• Supporting proposal writing experience.
• Strong knowledge of regulatory standards (FDA, EMA, ICH) and industry standards (GMP, GLP, GAMP).
• Experience with risk assessment methods like FMEA and root cause analysis.
• Excellent project management skills, including planning, scheduling, and budgeting.
• Detail-oriented with the ability to review technical documentation thoroughly.
• Strong communication and interpersonal skills for cross-functional collaboration.
• Willingness and ability to travel as needed for project assignments and client engagements.

Benefits

W2 temporary positions include medical and sick time benefits.

Equal Opportunity Employment

PSC is committed to equal employment opportunity, complying with all applicable laws. We prohibit discrimination based on protected statuses, including race, color, religion, sex, age, genetic information, or disability.