Description

Your Role:
The Lead Engineer, Quality Control shall provide technical validation support for processes, equipment, networks, software that has been newly installed, upgraded, replaced and modified in Quality Control. This role is the primary interface with Quality Control for Validations and Facilities on QC equipment.

Key Responsibilities:

• Take on lead role for select Capex and Opex projects within the QC department. This includes planning, project management, proposal, budgeting, and execution.
• Plan and procure new QC equipment as required.
• Plan and coordinate laboratory movement of QC equipment.
• Generate and review relevant documents for new equipment
• Schedule and manage routine PM on QC equipment
• Assess equipment needs for QC and manage equipment purchasing process
• Write and manage Engineering Change Request (ECR) documents
• Author User Requirement Specification (URS) and/or Requirement Specification documents for quality control equipment/systems and processes
• Generate and execute Installation, Operational and Performance/Process qualification (IQ, OQ, PQ) protocols and final reports that comply with corporate and regulatory requirements
• Coordinate and oversee validation protocol execution or validation activities
• Evaluate and analyze qualification data collected during projects while verifying acceptability of the data and compliance with the approved protocol
• Ensure any deviations to protocols and/or deviations to acceptance criteria are adequately addressed, documented and reviewed
• Improve validation and equipment processes
• Assist department manager in developing realistic time and resource requirements for validation activities in support of company expectations
• Provide input and assist in change control assessment and Part 11 assessment for validated systems
• Review Standard Operating Procedures (SOPs) and ensure the operational parameters described in the SOP for the equipment reflect validated conditions
• Assist department manager on other types of projects/managerial responsibilities as needed
• Schedule and manage routine instrument PM processes
• Occasional overnight travel by land and/or air may be required to attend seminars or conferences or client meetings
• Perform other duties as assigned

Minimum Qualifications:

• Requires a BA/BS in Science (such as Biology, Microbiology, Biochemistry, Chemistry) or other technologically related field plus 4-5 years' work experience in a biopharmaceutical/pharmaceutical manufacturing environment of which 3 years were directly involved in validations.
• Must have knowledge of validation principles, standard concepts, practices, procedures and requirements in a GMP regulated environment.
• An understanding of Good Automated Manufacturing Practice (GAMP), SDLC, Risk Assessment and 21 CFR Part 11 Electronic Records and Electronic Signatures required.

Position Type/Expected Hours of Work:

This role is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $105,000 - $124,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.