Summary: Performs all tasks necessary for internal filled container inspection processes. Works individually, and as part of a team, to manually inspect liquid and lyophilized vials and liquid syringes. Operates and maintains semi-automated and fully automated inspection equipment. Seeks to understand and develops proficiency in a wide range of processes or procedures of increasing complexity. Applies experience and skills to provide recommendations and solutions and also trains and provides guidance to other colleagues.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Performs the visual inspection of liquid and lyophilized vials and liquid syringes using manual inspection booths and/or semi-auto inspection machines.
• Operates automatic inspection equipment.
• Performs line clearance and cleaning activities of inspection booths and semi-auto and auto inspection machines.
• Supports the load and unload of inspection equipment when not performing visual inspection activities.
• Reviews, edits, completes and revises completed batch records, logbooks and SOPs in accordance with cGMP standards and compliant with written procedure.
• Completes training and maintains required qualifications for visual inspection.
• Coordinates to ensure process areas are stocked with essential equipment and components and ensures equipment and process operational readiness.
• Reconciles components and product according to SOP and Batch Record requirements.
• Ensures all tasks are performed in a manner consistent with cGMP SOPs and safety standards.
• Participates in equipment start-up, commissioning and validation activities.
• Assists with troubleshooting in case of equipment failure.
• Gathers, trends, and analyzes process generated data
• Supports investigations associated with internal inspection activities.
• Documents all training.
• Assists with training of new employees as directed.
• Assists and contributes in all areas of visual inspection as needed.
• Travel (domestic and international) may be required to support new equipment purchases and/or training.
• Must be able to lift/push/pull at least 40lbs.
Education and Experience:
• Requires AS/AAS degree in a physical or biological science or equivalent combination of education and experience.
Knowledge, Skills and Abilities:
• Ability to pass a visual acuity exam according to SOP requirements.
• Knowledge of cGMP manufacturing environment and familiarity with visual inspection of liquid and lyophilized products.
• Demonstrated strong interpersonal, cross-cultural, communication, negotiation and problem-solving skills.
• Exhibits confidence, has a high emotional IQ and demonstrated ingenuity, creativity and resourcefulness.
• Ability to gain understanding from provided instructions and work towards established goals individually or as part of a team.
• Understands and listens to team members and stakeholders' needs while supporting a positive team environment.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.