Job details

CQV Engineer

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 team’s 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®, it’s about more than just a job—it’s about your career and your future.

Your Role

We are hiring a driven and highly skilled CQV Engineer with a robust background in validation, manufacturing, and automation equipment.

Manage and execute validation projects from planning to completion, ensuring adherence to project timelines and deliverables.
Collaborate with cross-functional teams to establish validation strategies for various processes, equipment, and systems.
Develop and implement validation protocols and test scripts for automated manufacturing equipment and control systems.
Conduct risk assessments and impact analyses to identify critical process parameters and potential validation risks. Apply risk-based approaches to validation strategies.
Generate and review validation documentation, including Validation Plans, User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and validation summary reports, ensuring compliance with regulatory guidelines and internal procedures.
Create equipment identification forms and preventative maintenances on required equipment.
Evaluate and enhance validation procedures and methodologies to improve efficiency and compliance, while maintaining a high standard of quality and safety.
Assess the impact of changes to processes, equipment, and systems, and update validation documentation accordingly.
Represent the Validation team during regulatory audits and inspections, addressing validation-related inquiries and providing evidence of compliance.

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 applicant’s, employee’s, or intern’s 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.

#LI-RW1

Bachelor's degree in Engineering. 5+ years of commissioning, qualification, and validation engineering in the pharmaceutical, manufacturing, biotech, and/or medical device industries. Experience with automated manufacturing equipment and control systems, including PLCs, SCADA, and data integrity considerations. Advanced knowledge of associated validation documentation and reports. Strong knowledge of risk assessments, risk-based validation approaches, and quality risk management principles. Ability to make effective validation policy and program revisions when needed. Strong knowledge of User Requirement Specifications, Functional Requirement/Design Specifications. Knowledge of process and utilities validation techniques. In-depth knowledge of FDA regulations, cGMP guidelines, and other relevant industry standards. Knowledge of statistical tools and methodologies for validation data analysis. Strong analytical and problem-solving skills, with a keen attention to detail. Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present technical information to both technical and non-technical stakeholders. 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.

COMPANY RATING

4.6

Diversity & Inclusion

No rating

CEO of PSC Biotech Corporation

John Clapham

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By PSC Biotech Corporation

Our mission is to maintain quality and value of our products and services, enabling steady growth and development of our service area and offerings, while specializing in the areas of Validation, Quality and Compliance on an international scale. A...

8 jobs

SECTOR

Biotech & Pharmaceuticals

TEAM SIZE

201-500

LOCATION

Hybrid

DATE POSTED

August 5, 2023