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 350 clients in more than 23 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 seeking a Project Management Intern to oversee government contracts and to perform Commissioning, Qualification and Validation Activities in the Greater Maryland Area.
- Perform Project Management deliverables
- Work with key stakeholders to identify deliverables, responsible parties, expectations, and duration.
- Follow up with collaborators and work with key stakeholders to achieve project objectives and deliverables.
- Track changes on documents and process
- Communicate with collaborators about timeline and deliverables
- Process changes according to approved procedures
Commissioning, Qualification and Validation
- Performs commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments
- Authors protocols, initiates controlled documentation in support of CQV projects
- Provides project planning, management, execution, and follow up
- Reviews equipment specifications, manuals, and develops an understanding of how instruments work; tests equipment accurately to meet requirements for intended use
- Investigates failures and deviations; creates reports
- Analyses and reviews spare parts lists to ensure they are fit for purpose
- Reviews engineering drawings for accuracy and acts to correct errors
- Performs system walk-downs and makes changes using the change control of processes
- Initiates and resolves client Corrective and Preventative Actions (CAPAs)
- Provides analyses and summary reports
- Creates and maintains job plans, maintenance and PMs
- Pursuing a Bachelor of Science degree from an accredited institution in Science or Engineering.
- Demonstrates knowledge of Document Control fundamentals, Quality Systems, and GMP requirements.
- Demonstrates a general knowledge of the processes and impact of document control, and the relationship between the document change process and products.
- Demonstrates a basic understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc.
- Keeps abreast of the basic requirements for compliance in own work area.
- Demonstrates a high degree of attention to detail
- Demonstrates problem-solving skills.
- Demonstrates proficiency in Microsoft Office applications
- Demonstrates the ability to learn and adapt to various computer applications quickly.
- Demonstrates strong verbal, written, and interpersonal communication skills.
- Must be adaptable, customer service oriented, have a positive attitude
- This role requires additional hours worked. You must have a flexible schedule