Manager, Technical Transfer and Validation
- Madison, WI
Summary of Major Responsibilities
The Manager, Technical Transfer and Validation will be responsible for oversight of Validated systems and Technical Transfer of new products to Production. This position will work cross-functionally to oversee the development, planning, execution, and maintenance of Validation activities. This position will oversee process development, process characterization, process improvement, method development, and transfer of manufacturing processes and test methods through use of the Quality Management System. This position will lead team members driving initiatives that align with the business needs.
Essential Duties and Responsibilities
- Oversee the Validation Program and ensure compliance with the company’s Quality Management System (QMS) policies and procedures.
- Maintain the qualified state of validated systems (e.g., Equipment, Facility, Computerized Systems, Processes, Cleaning, Test Methods, etc.) through validation impact assessments using the change control process.
- Review quality documentation; including, but not limited to, Validation Plans, Validation Protocols, Validation Summary Reports, Inspection documents, manufacturing Work Instructions, and Failure Modes and Effects Analysis (FMEA) risk assessments.
- Lead validation review board meetings to review validation design strategy, validation deviation resolution, and regulatory impact.
- Serve as a project team member to provide validation guidance to streamline commissioning and/or development activities.
- Lead qualification and implementation of new raw materials and consumables into Operations.
- Oversee the design transfer process of new products to Operations and ensure compliance with the company’s QMS policies and procedures.
- Supervise process development, process characterization, process improvement, method development, and transfer of manufacturing processes and test methods.
- Develop or review Reagent Design Transfer Plans and Test Method Design Transfer Plans.
- Lead and facilitate continuous improvement or efficiency initiatives within cross-functional teams to improve cost of goods sold, drive reliability in process, and deliver quality.
- Serve as an extended team lead for Operations on new product projects and transfers collaborating with Research and Development or external vendors in developing, transferring, scaling, and validating manufacturing processes.
- Lead and support scale-up and capacity expansions efforts to drive productivity and meet company initiatives.
- Supervise staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
- Communicate goals clearly to employees to ensure understanding and success in achieving them.
- Motivate and inspire employees to do their best work through coaching.
- Maintain morale and support employee engagement initiatives.
- Strong documentation, attention-to-detail, and procedure writing skills suitable for a GMP environment.
- Strong analytical, problem-solving skills, and negotiating skills; ability to make decisions with limited information and operate with autonomy.
- Ability to effectively work on many complex and varied projects at one time, with frequent changing priorities.
- Excellent oral and written communication, strong interpersonal skills.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ability to lift up to 50 pounds for approximately 5% of a typical working day.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability and means to travel between Madison locations.
- Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
- Bachelor's degree in Biology, Molecular Biology, Chemistry, or a science related field; or Associates degree and 2 years of relevant experience in Biology, Molecular Biology, Chemistry, or a science related field in lieu of bachelor’s degree.
- 8+ years of experience in a current Good Manufacturing Practice (cGMP) environment.
- 3+ years of experience in Process Validation principles and practice.
- 3+ years of direct leadership experience.
- Proficient in Microsoft Office.
- Proficient in statistical and mathematical methods in biology/genetics.
- Proficient in knowledge of IVD product Manufacturing processes, Product Design, and Development.
- Professional working knowledge with 21 CFR Part 820, ISO 13485, and/or cGMP structured environments.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
- 7+ years of validation experience in a medical device manufacturing environment.
- 3+ years of experience with Project Management principles and practice.
- Experience working within Enterprise Resource Planning (ERP) systems such as SAP.
- Strong knowledge in Design for Six Sigma and Statistics.
- Strong knowledge in basic and advanced continuous improvement methodologies/ principles such as LEAN Six Sigma and/or Practical Process Improvements (PPI).
- Experience with Project Management principles and practice.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.
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