Our client, a leading pharmaceutical company is hiring a Validation Engineer on a contract basis.
Work Location:
Devens, MA – 100% on site
Knowledge/Skills Required/Education:
- Specific technical skills with biopharmaceutical processing including a minimum of 5 years of experience developing and/or testing process automation system software (preferably Delta V batch). Understanding of S88 and batch processing operations required. Practical experience with large scale distributed control systems required.
- Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
- Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
- Comprehensive DCS and PLC based experience, preferably gained in the pharmaceutical industry.
- Knowledge of procedural batch processing automation in a Delta V environment.
- Knowledge of a system life cycle validation techniques for automation software specification and development.
- Familiar with construction techniques and automation system hardware installation practices.
- Experience with dealing with recognized large automation providers (Emerson, Rockwell preferred).
- Familiarity with distributed control systems and automation (GAMP) validation concepts allows this individual to participate in cross-functional validation efforts. A working understanding of lean principles is a suggested.
- Demonstrated proficiency in project management, oral communication, and technical writing skills are required.
- The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.
- Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent.
- Work both independently and in a team environment at all levels of the organization, in particular Quality, Engineering and Manufacturing Operations.
- Work within all Site Facilities, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE).
Responsibilities:
- Leads the validation efforts associated with the operation of all GMP manufacturing systems (Process Automation System, Manufacturing Execution System (MES)) in a highly automated biologics manufacturing facility.
- Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Process Automation System (Delta V).
- Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Manufacturing Execution System (Syncade).
- Executes and/or leads validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs.
- Develops appropriate validation methodologies in collaboration with Operations management and Quality Assurance for novel projects.
- Leads a portfolio of validation projects under strict deadlines to ensure stakeholder success and bulk drug supply.
- Executes and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.
- Provides validation subject matter expertise (SME), to multi-function teams, advises operations on validation matters, and defends their work before regulatory agencies.
- Ensures alignment with client directives and industry guidelines on validation.
- Duties may include internal compliance or efficiency improvement efforts within department.