Equipment Validation Engineer

Job Description

PSC Biotech provides the lifesciences 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 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 motivated and

hands-on engineers with direct experience in commissioning, qualifying, and

validating pharmaceutical manufacturing facilities, utilities, and large-scale

process equipment. This role is critical to ensuring the successful startup and

compliance of complex systems used in regulated environments. You will be

responsible for developing and executing validation protocols, troubleshooting

equipment, and generating comprehensive lifecycle documentation.

Develop and execute commissioning, qualification, and

validation protocols (IQ / OQ / PQ) for cleanroom environments and large process

equipment.

Write and review technical documentation including

specifications (URS, FS, DS), SOPs, risk assessments, and final reports.

Collaborate with cross-functional teams to ensure validation

activities align with project timelines and regulatory expectations.

Conduct impact, gap, and risk assessments to identify

potential issues and implement mitigation strategies.

Analyze test data and acceptance criteria to ensure accuracy

and compliance.

Operate and troubleshoot equipment during startup and

validation phases to assess performance and recommend modifications.

Ensure all validation activities meet current industry

standards and regulatory requirements (cGMP, FDA, etc.).

Additional responsibilities as needed to support project

deliverables.

Requirements

Bachelor’s degree in Engineering or a related technical

field.

2 – 7 years of hands-on experience commissioning,

qualifying, and validating process equipment within the pharmaceutical manufacturing

industry.

• Experience qualifying cleanroom facilities.

Experience in large process equipment in pharmaceutical

manufacturing (vessels, centrifuges, filter presses and CIP skids).

Experienced writing and

generating technical validation documentation including final summary reports, IQOQPQ

protocols, specifications (URS, FS, DS), operating procedures, etc.

Proven knowledge of regulatory

requirements and industry standards (cGMP, FDA, etc.).

Strong understanding of

risk-based validation approach.

Excellent analytical, problem-solving, and communication

skills.

Ability to manage multiple projects and work both

independently and collaboratively.

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

Adhering

to the requirements of California's law on salary transparency, the salary

bracket for this role is set between $85,000

various factors such as the applicant's qualifications, skills, and

professional experience.

​Equal Opportunity Employment StatementPSC 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.

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