DIRECTOR OF ENGINEERING

100% onsite at Thorne's manufacturing location in Summerville, SC. Relocation available.

At Thorne we make products that matter - ones that make people's lives better. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. You’ll be joining a team of more than 700 passionate individuals committed to our cause of providing superior health solutions.

POSITION SUMMARY: Responsible for the daily operation and administration of Thorne Engineering & Validation Teams. Working with the team, responsible for driving development and execution of process improvement measures, new product/formulation/reformulation input, component specification input, new manufacturing and plant support equipment specification, and validation of equipment and processes.

FLSA STATUS: EXEMPT employee.

RESPONSIBILITIES – Satisfactorily performing and/or achieving the following Responsibilities are essential duties of the job.

• As defined by VP, Engineering, ensure team’s resources are used to increase efficiency, reduce labor costs and maximize product yield.
• Ensure compliance with Thorne policies as well as federal, state, and local regulatory bodies, and other quality agencies, manufacturing standards, and certifying agencies.
• Establish key performance metrics and monitor performance to ensure that progress is being made and corrective action, if necessary, is promptly taken.
• Working with VP Engineering and team, develop annual operating budgets, capital plans, and periodic updates, recommend staffing and provide ongoing monitoring of spending against plan.
• Ensure cooperation and alignment between functional groups. • Keep the VP of Engineering informed of project status, potential threats, opportunities, and recommended actions. • Ensure engineering, validation and technical support is provided to Thorne operations.
• Ensure the Clinical Trial process is supported – including, but not limited to – engineering resource assignment, review & approval of Manufacturing Protocol, proof of principle and bench work.
• Ensure support of New Product Introduction Process, through the initial approval and trial phases – including, but not limited to – engineering resource assignment, formula review, proof of concept, and pilot batch development.
• Be a resource for the team to review and oversee new manufacturing equipment specifications, URS’s, acceptance testing (SAT & FAT), draft operation SOP’s and validations/qualifications.
• Working with Engineering and Operations personnel, ensure the current capabilities of all Thorne production equipment is understood, documented, and kept current.
• Ensure procedures within Engineering & Validation groups are defined, documented (SOP’s, WI’s, forms) and maintained. This includes, but is not limited to, research and development activities, equipment specifications/URS, lab equipment, procedures, machinery and process Validations and material classification protocols.
• Qualification Master Plan Authority. Responsible for Production Critical Equipment Qualification and Requalification (resource assignment, development, scheduling, and implementation, review & approval of related documentation).
• In the absence of Engineering or Validation Managers, review and/or approve the following documents including, but not limited to: Master Formulas, Formula Changes, MMR’s, Component Specifications, Raw Material Specifications, Finished Product Specifications, Production Equipment SOP’s, forms and Work Instructions, Validation protocols, and OCM specifications.
• Support manufacturing-related Corrective and Preventive Actions (CAPAs) as required.
• Review and add to regular, accurate Engineering & Validation status reports (project status, issues, schedule adherence, and other items as deemed necessary) and submit weekly to VP of Engineering.
• Provide Engineering and/or Validation presence on the production floor to monitor processes and/or troubleshoot issues.
• Daily review of production pass downs for issues pertaining to Engineering and/or Validation or requiring Engineering and/or Validation assistance.
• As a member of the Material Review Board (MRB), oversees the review and recommended disposition of any finished product or raw materials received that are out of specification.
• Build and lead a highly performing team, secure the best talent, develop, mentor, and strengthen staff and future leaders, and provide ongoing coaching and feedback.

What You Need:

• BS or MS in Engineering, Physical, or Life Science is required.
• 25+ years’ related experience in Pharmaceutical, Biopharmaceutical, or Dietary Supplement Manufacturing,
• 5+ years’ experience in a Director or Sr. Engineering Management position, and
• 7+ years’ experience in an FDA-regulated environment.
• Experience with ISO and/or cGMP standards required.

What We Offer:

A little bit more about us:

THORNE IS AN EQUAL OPPORTUNITY EMPLOYER

Thorne values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, sexual orientation, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

Must be able to safely work with ingredients and products that are derived from possibly allergenic sources including, but not limited to, nuts, soy, dairy, fish, and shellfish.