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\xe2\x80\x99 success, and you can be a part of our team\xe2\x80\x99s 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\xc2\xae 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\xc2\xae, it\xe2\x80\x99s about more than just a job\xe2\x80\x94it\xe2\x80\x99s about your career and your future.

Your Role

We are looking for senior-level Commissioning, Quality and Validation (CQV) Engineer. The CQV Professional would work alongside an amazingly talented PSC Team and works under the leadership of one of the best in the industry.

• Provide CQV authoring, review and approval of validation documents developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards.

• Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.

• Draft and execute validation documentation

• Validation Project Plan

• Requirement Specification (URS, DS, FS)

• IQ and OQ Test Scripts

• IQ/OQ/PQ Protocols, as necessary

• Validation Summary Report

• Develop risk assessments associated with validation activities.

• Collaborate with multiple departments on assigned project activities and deliverables.

• Provide support and mentor validation team members.

• Provide support to executors of the protocols when needed.

• Write reports summarizing system validation.

• Clearly communicate all progress, updates, and action steps for assigned projects.

Requirements

• Bachelor\'s Degree in a relevant science or engineering field, or equivalent years of hands-on experience.

• 7+ years\xe2\x80\x99 experience in the biotechnology and pharmaceutical industries with a minimum of 3-5 years relevant experience performing CQV activities within GMP environment.

• Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines (aseptic processing, cleanroom utilities). Prior manufacturing/Facility Startup experience is preferred.

• Experienced in CQV of facility/utility/equipment, including WFI, RO, HVAC, Building Management Systems and process equipment, etc.

• Understands current risk-based validation approaches.

• Experience in authoring, revising, reviewing, and completing controlled documents for validation projects.

• Experience generating design specifications (URS, FS, DS).

• Experience with system impact assessment and risk assessment.

• Provide leadership from a validation perspective to a cross functional team where interaction with multiple groups is required to coordinate, plan, and implement work.

• Excellent organizational skills

• High attention to detail

• Must have strong written and verbal communication skills

• Good knowledge of the code of GMP and PIC/S code

• Previous experience in Life Sciences Industry is required

• Previous experience in GxP Industries are required

• Must be adaptable, customer service oriented, have a positive attitude

• Able to travel domestically and internationally.

Benefits

Offering a full suite of benefits, PSC Biotech\xe2\x84\xa2 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 - PSC matches, dollar for dollar, employees investment into the 401(k) plan up to 6%.

• 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\xe2\x80\x99s, employee\xe2\x80\x99s, or intern\xe2\x80\x99s 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-TW1

PSC Biotech