Validation Project Manager

Job description

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients success, and you can be a part of our teams achievements.

Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special.

When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers.

As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech, its about more than just a jobits about your career and your future.

Your Role The Validation Project Manager delivers comprehensive support to clients throughout every stage of the CQV lifecycle, offering expert guidance in project planning, strategic development, and execution, employing a risk-based methodology to ensure adherence to regulatory standards and the highest levels of product safety.

Successful candidates will be well-versed in laboratory equipment validation.

Drive project success by assessing priorities and project plans, schedule, and budget, and ensure timely and effective resolution of potential risks and issues.

Develop and execute commissioning, qualification, and validation protocols for required laboratory equipment and systems.

Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures.

Identify and assess risks associated with CQV activities and develop mitigation strategies.

Troubleshoot and resolve issues related to equipment and process performance.

Collaborative with cross-functional teams to ensure alignment on CQV activities and project timelines.

Serve as liaison between vendors and contractors, coordinating required hand-offs.

Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).

Provide ongoing support and technical expertise through validation execution and qualification activities.

Requirements Bachelors degree in engineering or a related field.

7-10 years of commissioning, qualification, and validation engineering experience in the pharmaceutical industry.

Experienced in project management methodologies and tools, with proven success in overseeing and leading critical CQV projects.

Well-versed in the validation of analytical laboratory equipment such as HPLCs, liquid chromatography, controlled temperature units, etc.

Experienced coordinating schedules, timelines, resources, and budgets.

Advanced knowledge of regulatory requirements and industry standards.

Experience with validation lifecycle management and risk-based approaches.

Expertise in full CQV project lifecycle execution from planning, initiation, execution, and closeout.

Excellent analytical and technical problem solving skills.

Ability to analyze project risks effectively and implement resolutions.

Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.) Effective communication and interpersonal skills.

Ability to manage stakeholder communication and cross-functional team collaboration.

Proactive with strong organization and time management skills.

Excellent attention to detail with commitment to quality and compliance.

At PSC Biotech, many of our projects and clients are located in various regions around the country.

Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements.

The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.

Must be authorized to work in the U.S No C2C at this time Benefits Offering a full suite of benefits, PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success.

We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.

401(k) and 401(k) matching PTO, Sick Time, and Paid Holidays Education Assistance Pet Insurance Discounted rate at Anytime Fitness Financial Perks and Discounts Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment.

Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination.

Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs.

Employment decisions will be made without regard to an applicants, employees, or interns actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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2-5 years

Required Skill Profession

Other General