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 mid-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.
Successful candidates will have excellent verbal and written communication skills, and a thirst to learn.
Responsibilities:
- Provide CQV 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 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 validation documentation
- Validation Project Plan
- Requirement Specification (URS, DS, FS)
- IQ and OQ Test Scripts
- IQ/OQ/PQ Protocols, as necessary
- Traceability Matrix (TMX)
- System Release Memo
- 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
Demonstrated Competencies:
- Relationship Building – Works with and across formal and informal professional and social networks to build long-term partnerships and connections in the life science industry.
- Time Management – Able to follow strict deadlines, prioritize tasks, and work well under pressure.
- Customer Service - Ability to interact with professionals and customers outside of the company.
- Analytical Skills – Identifies, researches, and demonstrates logical reasoning to communicate critical information.
- Interpersonal Awareness – Ability to be aware of how actions, ideas, and communication can/does affect people and their outcomes.
- Agility – Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines.
Requirements
- Bachelors Degree in Chemical Engineering, Biomedical Engineering, or related degree from a 4 year University
- The ability to travel or relocate is preferred but not required
- Must have strong written and verbal communication skills
- 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
- No C2C/ No Sponsorship
