Employment Type : Full-Time
Equipment Validation Engineer, San Diego, Orange County, Los Angeles and San Francisco Duration: 12+ months PURPOSE AND SCOPE OF POSITION: 3. DUTIES AND RESPONSIBILITIES
Onsite role from Day 1
The Equipment Engineer, Equipment Commissioning & Qualification Operations (S6A) supports the successful operation of laboratory and clinical manufacturing operations at their home site through interaction with internal team members and internal customers as well as external service providers. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization. The incumbent may be asked to lead small to medium sized projects in their area of responsibility and will be called upon to create and revise work processes or procedures that impact their immediate function or organizational unit. The incumbent will be involved with writing deviations, investigations and supporting the implementation of change controls.
2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required.
• Strong multi?tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
• Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
• Working knowledge of scheduling software and systems, and inventory management systems, mainly Blue Mountain RAM, Maximo
• Ability to interact effectively with Manufacturing Operation, QA and Facilities groups.
Operational Activities
• Executes equipment calibration, preventative maintenance, performance verification and repair activities in both laboratory and manufacturing areas.
• Supervises vendors for calibration, preventative maintenance, performance verification and repair functions.
• Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, completeness and compliance to Bristol-Myers Squibb standards.
• Works closely with and enters data into the site CMMS system.
• Ensures all calibration, PM, and performance verification records are filed appropriately after approval.
• Writes and supports Change control and relevant action
• Writes and supports deviations and investigations that result from calibration or performance verification failures along with developing and supporting the implementation of corrective and preventative actions.
• Support the development, revision and review of written procedures for calibration, preventive maintenance and performance verification of equipment.
• Support the development, review and approval of calibration and maintenance plans in site CMMS system.
• Supports the execution of equipment performance verification and process improvement studies.
• Adheres to all policies and procedures which govern the ECQ team and the equipment they manage in order to ensure compliance is held to the highest standard.
Promotes and Provides Excellent Customer Service and Support
• Regularly reviews, prioritizes and promptly responds to customer equipment performance verification and support requests.
• Provides technical support and guidance on calibration, equipment performance verification and validations issues. Interfaces with customers to ensure all expectations are being met.
• Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
Inventory Management
• Work with planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed.
Regulatory Responsibilities
• Maintains all required Corporate, Facilities and EHS training as required.
• Adheres to all safety procedures and hazard communication.
• May be called upon to act as SME in both internal and regulatory audits.
4. EDUCATION AND EXPERIENCE
• BS in Engineering or Science related discipline preferred.
• Minimum 2 years’ experience in FDA-regulated industry
• Experience working directly with biologics manufacturing equipment (Single Use Bioreactors, Chromatography, TFF skids, single use mixer, osmometer, Autoclave, Spectro photometer etc.) preferred.
• Knowledge of cGMP in the pharmaceutical industry
• Excellent computer skills including knowledge of calibration management and environmental monitoring systems
• Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required
• 2 years of maintenance coordinating / planning experience, preferably in a laboratory environment.
• Experience working in a clinical environment preferred.