Engineering Supervisor

As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.

The Engineering Supervisor, reports to Sr. Manager, Engineering, and is responsible for providing direction and oversight to the Validation Engineering group and assurance that the equipment lifecycle management activities are in adherence with regulatory (GxP), corporate requirements, and site requirements for Ferring Microbiome Technical Operations division.

This role will be expected to provide leadership to the Validation Engineering group and key support for the equipment qualifications, computerized system, and material qualifications. Development, review and approval of system validations and infrastructure qualification documentation and protocols.

This role is also expected to support the Strategy for Computer System Validation (Including Data Integrity) of Process Equipment, Lab Systems, Equipment qualifications, Facility qualifications Material qualifications for both commercial and clinical stage manufacturing.

Additional responsibilities for the Engineering Supervisor will be to lead the execution, identify escalating risks and opportunities in a timely manner and provide periodic status reports to Stakeholders.

A key aspect of this role will be to partner with System/Process Owners, Quality Departments, External Vendors etc., to define and lead the Engineering Validation group, to execute Validations and Equipment Qualifications with strong risk-based approach, support internal and external audits, identify opportunities to improve methodologies.

This role is expected to collaborate cross-functionally and lend support to diverse initiatives as directed by management to achieve departmental goals

• Partner with Quality Assurance teams, external vendors, and the end user community to continuously improve, educate and reinforce best practices throughout the Computer and Equipment lifecycle.
• Partner with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the validation department.
• Perform gap analysis of validation documentation, systems, and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Perform periodic system reviews with business and system owners.
• Report key metrics and generate or review/update related policies, procedures, templates, forms, etc.
• Provide active support during regulatory agency and third-party inspections.
• Research new technologies, understand existing processes, and reference recognized standards and frameworks.
• Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned.
• Identify opportunities for continuous improvement.
• Supervise and mentor direct reports as designated by department management

• College degree (life sciences degree preferred) or equivalent experience.
• Minimum 5 years of experience providing oversight for Validation projects.
• In-depth knowledge of 21 CFR Part 11, Annex 11, GAMP 5 and Data Integrity concepts.
• 2+ years Supervisory or Lead experience
• 5+ years experience in the Biotech/Pharmaceutical Industry or similar, regulated industry required
• Excellent analytical, interpersonal and communication skills, including written and verbal communication
• Investigation and CAPA experience preferred
• Previous experience as validation engineer for a life sciences company regulated by the FDA required
• In-depth understanding of industry accepted software development and validation life cycle programs.
• Previous experience in risk-based approach to validation systems a plus.
• Demonstrated ability to interpret cGMP, 21
  
  CFR 210 and 211, 21
  
  CFR part 11, Annex 11, GAMP 5 and other applicable regulations, standards, and guidance.
• Knowledge of working with quality systems within the…