GENERAL PROJECT DESCRIPTION

Plant site has the need to recruit a subcontracted resource to execute the position of Pilot Plant TSMS Engineer to help the process team with equipment-related projects in the Fermentation Pilot Plant.

B. SCOPE & RESPONSIBILITIES

Under limited supervision and in accordance with the laws, federal regulations, and applicable state and local policies, procedures and guidelines, this position has the following tasks and duties.
• Understand the basic scientific and engineering principles required for fermentation manufacturing processes.
• Understand how process requirements, as established in operational instructions, procedures, process flow documents, etc. translate into field execution.
• Review production instructions and serves as the co-owner in the preparation, revision and approval of operational instructions.
• Provide technical support for the operational troubleshooting and implementation of identified countermeasures.
• Perform tasks related to fermentation process (i .e. discharge tanks, material handling, raw material charges, equipment cleaning, in-process testing, etc. )
• Provide support to the management of daily operations, including 24hr/7days technical support
• Attend and participate in Process Team meetings/Weekly Huddles.
• Have understanding of operational control strategy and how the equipment impacts key process parameters.
• Lead/Support execution and technical documentation related to Equipment related Events, Corrective Actions Preventive Actions (CAPAs) and Changes, as applicable.
• Provide technical expertise for installation, operation, maintenance, and reliability of pilot plant process equipment.
• Have holistic understanding of Process Validation (and associated equipment, facilities, and computer systems), assessment of significant changes, maintenance and other interventions, involvement with Preventive Maintenance (PM) Plans and spare parts list. Assist in preparation of verification documents, participate in the execution of the activities, and support the approval.
• Makes decisions within guidelines and policies and ensures compliance with all requirements, policies, and regulations.
• Ensure safety processes (procedures, training, and equipment) are in place (i.e., Lockout/Tag Out [LOTO], Line breaking, etc.) for pilot plant activities.

C. MINIMUM REQUIREMENTS

• BS Engineering (Chemical or Mechanical).
• 2-4 years of experience with bulk pharmaceutical operations equipment is required.
• Excellent technical and quality documentation skills in English.
• Experience and knowledge of Fermentation processes is preferred.
• Computer systems validation experience in regulated operations (preferably GMP operations).
• Able to use a logical, systematic approach to problem solving.
• Ability to manage multiple projects and prioritize work based on business needs.
• Strong communication, teamwork and collaboration skills.
• Available to work or provide support to a 24/7 operation.

D. RELEVANT COMPLIANCE DETAILS

Compliance
The contractor shall complete the required compliance training such as “The Red Book”; apply knowledge, principles, and requirements to daily work and in business relationships with customers, suppliers, employees, stakeholders, etc.

Safety
Safety is our number one priority. The contractor shall comply with the requirements established in the Security Policy, Occupational Safety and Industrial Hygiene Policy, Standard Operational Procedures (SOPs) and Basic Safety Rules. The Contractor must comply with all safety and security requirements. Contractor company must provide all the personal protective equipment (respiratory protection, safety shoes, etc.) and provide the medical surveillance documentation to comply with OSHA requirements.

Environmental
Use all office supplies in an efficient manner. Recycle or re-use paper, glass, carton/mill-board and any other recyclable material. Observe, promote and comply with EPA and internal environmental standards as appropriate.