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 an experienced CQV Engineer to join our team! CQV Engineers are responsible for the
commissioning, qualification, and validation for facilities,
utilities, and equipment in the pharmaceutical and biotech
industries. Our engineers play a critical role in driving
project success, while supporting validation planning,
development, documentation, and execution, and ensuring
regulatory standards and quality requirements are met.
Develop and execute
commissioning, qualification, and validation protocols for
required 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 effective
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.
Ensure compliance
with regulatory requirements (FDA, EMA, etc.) and industry
standards (GMP, GAMP, etc.).
Additional
responsibilities as required to drive successful validation
project deliverables.
Requirements
Bachelor’s degree
in Engineering, Life Sciences, or a related field.
5 years minimum of
equipment commissioning, qualification, and validation
engineering experience in the pharmaceutical and/or biotech industries.
Strong knowledge of
regulatory requirements and industry standards.
Experience with
validation lifecycle management and risk-based approaches.
Excellent
analytical and technical problem solving skills.
Strong technical
writing skills and understanding of full lifecycle
documentation (protocols, reports, procedures, risk
assessments, specifications and requirements, etc.)
Effective
communication and interpersonal skills.
Proactive with
strong organization, time management, and project
management abilities.
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 are essential, as
it allows our team members to collaborate
effectively with clients and colleagues nationally.
Must be authorized to
work in the US.
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 Biotech 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.
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