CSV Engineer

PSC Biotech is a leading process consulting and contract engineering company. For over 25 years we have been engaged in providing laboratory support, project management, engineering, and validation support to top-tier pharmaceutical and biotech companies.

Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies with services designed to help achieve regulatory compliance requirements. PSC Biotech Corporation serves over 1000 clients in more than 35 countries through professional services consulting, cloud-based software solutions, and pharmaceuticals contract manufacturing. PSC Biotech Corporation has three unique active divisions within the parent company, each representing one of our areas of expertise: PSC Biotech™, PSC Software™, and BioTechnique™. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.

We are looking for a mid-level Computer System Validation Engineer.

Responsibilities:

• Provide CSV authoring, review and approval of validation documents developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards.
• Initiate/update GxP and Risk Assessments on system.
• Author, Review and or approve scheduled periodic reviews.
• Author, Initiate, and/or review and approve IT SOPs related to compliance
• Collaborate with project stakeholders and the information systems team to define needs and achievable solutions and/or justifications to system requirements
• Draft and execute computer system validation documentation

o Validation Project Plan

o Requirement Specification (URS, DS, FS)

o IQ and OQ Test Scripts

o IQ/OQ/PQ Protocols, as necessary

o Traceability Matrix (TMX)

o System Release Memo

o Validation Summary Report

• Translate system requirement specifications into executable validation protocols
• Provide support to executors of the protocols when needed
• Write reports summarizing system validation

Requirements

• Bachelor's Degree in Chemical Engineering, Biomedical Engineering, Computer Science or IT/IS from a 4 year University
• 3-5 years of CSV experience is required
• Previous experience in GxP Industries / Life Science Industries is required
• Ability to travel or relocate is preferred but not required
• Must have strong written and verbal communication skills
• Ability to travel a minimum of 50% is required.

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 - 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 24 Hour Fitness
• Financial Perks and Discounts