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 multicultural 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 an experienced CQV Engineer to support commissioning qualification and validation development and execution activities. Candidates should have experience in clean room and environmental monitoring qualification.
Develop and execute IQ OQ PQ protocols ensuring adherence to regulatory and industry requirements. Draft review and author protocols procedures summary reports exceptions risk assessments and additional required technical documentation. Support documentation updates as needed in required standard operating procedures forms and so on. Perform acceptance testing and evaluate qualification data and results ensuring alignment with acceptance criteria. Responsible for maintaining and developing qualification activity schedule. Support additional cleaning validation tasks as needed.
Proactively drive successful project completion and deliverables taking on project coordinating tasks as required.
Additional responsibilities as required. Requirements Bachelors degree in related engineering discipline. 35 years of commissioning qualification and validation engineering experience within the pharmaceutical manufacturing/life science industry. Experienced in clean room qualification. Experienced in environmental monitoring qualification. Cleaning validation experience is a plus. Proven technical writing skills in order to produce accurate and quality technical documentation including protocols procedures reports etc. Strong understanding of cGMP regulations and quality compliance. Excellent communication skills both verbal and written. Strong attention to detail with a commitment to quality and accuracy. Excellent time management and organization skills. Strong analytical analyses and problem solving skills. 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. 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
Estimated annual salary (dependent on experience) $85000 $100000.
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 employersponsored 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.
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Bachelor 's degree in related engineering discipline. 3-5 years of commissioning, qualification, and validation engineering experience within the pharmaceutical manufacturing/life science industry. Experienced in clean room qualification. Experienced in environmental monitoring qualification. Cleaning validation experience is a plus. Proven technical writing skills in order to produce accurate and quality technical documentation including protocols, procedures, reports, etc. Strong understanding of cGMP regulations and quality compliance. Excellent communication skills, both verbal and written. Strong attention to detail with a commitment to quality and accuracy. Excellent time management and organization skills. Strong analytical, analyses, and problem solving skills. 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.
