Automation Validation Specialist - Lancaster, United States - NavitsPartners

Description

Job Description

Position: Automation Validation Specialist
Location: West Point, PA
Duration: 6 months

Job Description:

• This role is to provide automation support to our vaccine manufacturing facility.
• Responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations.
• Actively support, participate and embrace a diverse and inclusive culture including significant interaction with manufacturing, quality and engineering groups. Supports a broad spectrum of automated systems within GMP Manufacturing Operations.

Key Functions:

• Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Provide automation system support and expertise to assist the manufacture of quality vaccine products to meet site priorities.
• Responsible and accountable for supporting all automation system components of the processes including on the shop floor support of manufacturing activities
• Responsible for designing, implementing, testing, and closing-out change controls for automation related corrective actions and continuous improvement initiatives.
• Participate in investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions.
• May require to provide off-site weekend/evening automation phone or on-site support as needed.

Education: Bachelors preferred but Associates acceptable (with good experience).

Required:

• 3+ years in process automation or equivalent in pharmaceutical/ biotechnology industry.
• Familiarly with Computer system validation and regulatory GXP requirements.
• Knowledgeable of S88 Batch Standard
• Strong communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external parties.
• Technical and operational expertise in automation control systems such as Emerson DeltaV, AB PLC, Factory talk, SCADA, Windows operating systems, network infrastructure, SQL, etc.