Analytical Services Equipment Responsible

Quality

Each individual is responsible to meet fundamental cGMP requirements relating to their conduct and work practices to ensure the appropriate quality of the products manufactured at Evonik Birmingham Laboratories. 

This includes but is not limited to the following:

• Adherence to all written instructions.
• Timely reporting of all deviations to supervision.
• Training on each activity is completed and current and that each employee understands their assigned duties.
• Strict documentation practices are followed to ensure that all steps of the operation are appropriately documented.
• Ensure to maintain the work area in a state of cleanliness and sanitation through good housekeeping practices and applying good personal health practices.
• Ensure the security and safety of the product through the reporting of any potential risk to supervision immediately.
• Ensure the safety of the personnel and product by wearing proper PPE (Personal Protective Equipment) according to the operation being executed.
• Each individual should report any action that they believe could impact the quality of any product immediately to supervision.

Environmental, Safety, Health, & Security (ESHS)

• Adhere to ESHS programs, rules, & procedures.
• Assume personal accountability for individual behaviors related to ESHS activities.
• Have the appropriate knowledge and tools prior to performing a task.
• Complete all required ESHS training and remain current with applicable learning plans at all times.
• Report all injuries to Employee Health Services or Security and supervision within the same shift of the incident occurring.
• Inform direct supervision of any ESHS hazards or concerns in the workplace.
• Provide feedback and coaching to coworkers on both safe and unsafe behaviors and conditions.
• Actively participate in the ESHS management system as directed by supervision.

PRINCIPAL ACCOUNTABILITIES:

• Manages the process of installing and qualifying new instrument projects from procurement to final qualification and ready for use

• Owner of equipment qualification process for AS labs
• Leads project meetings providing updates, milestones and communicates project status
• Manage installation/qualification activities with shops, IT, safety personnel, and vendors, including USWP for vendors as required.
• Safety pre-qualify vendors as appropriate
• Drafting procedures, work instructions and training
• Manage the process for identifying new equipment needed for the department
• Write/revise user requirements and customer requirements for new equipment
• Manage equipment projects to support the lean QC initiative

• Investigates new technologies for laboratory equipment to improve laboratory through-put and capabilities

• Write/revise annual contracts with vendors, ensure termsand conditions are in place and route for approval
• Writes and revises Maintenance Strategies for lab instruments
• Coordinating requalification and OQ process for laboratory equipment
• Oversee process for decommissioning laboratory equipment
• Audit SAP records for correctness and completion
• Author/Investigator for TrackWise deviations and changes
• Manage equipment documents for audits that involve laboratory equipment
• Works with contract personnel and vendors to coordinate and provide maintenance services.
• Assist Stability Supervisor for stability maintenance activities
• Manages safety efforts for equipment improvements for the department
• Coordinates individuals from multiple departments for improvements/issues that impact equipment operations in the lab
• Ensures the process for maintaining logbooks is in compliance
• Coordinates lab activities during plant shutdowns and power outages
• Back-up for maintenance laboratory personnel 
• Understand Birmingham priorities to better manage the business of the site
• Responsible for issue resolution and will serve as lead investigators, change owners, and procedure subject matter experts
• Be an advocate and champion for change initiatives which can improve current procedures, method, processes, etc.  Identify, lead, investigate, and implement changes as necessary.

REQUIREMENTS

• BS in Physical Science/ FE College (2 A Levels)
• Sound experience and understanding of straightforward procedures or systems
• Abolity to work on complex analystical equipment and repair as needed.
• Works to develop appropriate plans or perform necessary actions based on recommendations and requirements.
• Works to analyze data trends