100% onsite position

Please note that this position is contract to hire after 6 months

Duration: 6 months( Contract to hire after 6 months)

Must Haves-Computer system validation, MES, Process control systems and experience in Biotech industry

• 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.

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.

Education:

• 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).

Exercises sound judgment in making decisions and recommendations within generally defined practices and policies without management review.

• May make decisions and take action on standard cases without management review.
• May work on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
• Acts as an advisor to subordinates and becomes actively involved as required to meet schedules or resolve problems.
• Erroneous decisions or failure to achieve results may have significant financial implications or cause significant delays in schedules.
• Incumbent performs all tasks completely independently, determining methods and procedures on new assignments. Receives assignments in the form of objectives and establishes goals to meet objectives.
• Completes projects and unusual or complex assignments with only general review from manager. Identifies and reports any discrepancies from normal practices or procedures to management, recommending and implementing corrective actions, when consensus cannot be reached.

Job Type: Contract

Salary: $47.95 - $67.00 per hour

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Day shift

Work setting:

• In-person

Ability to commute/relocate:

• Devens, MA 01434: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Computer system validation: 5 years (Preferred)
• Manufacturing Execution System(MES): 5 years (Preferred)
• Process Automation System (Delta V).: 5 years (Preferred)
• Mastery of SOPs, cGMPs and other compliance requirements: 5 years (Preferred)
• large scale distributed control systems: 5 years (Preferred)
• pharma industry: 5 years (Preferred)

Work Location: One location

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