Are there specific educational/software requirements needed?
-Doctorate OR
-Master + 2 years of Scientific experience OR
-Bachelors + 4 years of Scientific experience.
Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Materials Science, Pharmaceutical Sciences, or related field.
Training in vision systems (i.e., Cognex, Systech, Syntegon, Koerber, A3 CVP, PDA 593)
What attributes (i.e. - preferred qualifications) would make this candidate stand out?
1. Automated Visual Inspection (AVI) Expertise (Key Differentiator - Highly Desired)
• Direct experience with automated visual inspection systems, such as:
o Machine vision–based inspection platforms
o Camera systems, lighting optimization, optics
o Image acquisition and defect detection logic
• Knowledge of AVI system qualification and validation:
o IQ/OQ/PQ
o Performance qualification using defect kits
• Experience developing or supporting:
o Inspection recipes
o Defect libraries and defect standards
o Sensitivity and false reject optimization
• Familiarity with manual vs automated inspection correlation
2. Data, Statistics & Digital Skills (Preferred)
• Strong statistical background, including:
o Sampling plans (AQL, zero acceptance, etc.)
o Inspection capability studies
o Measurement system analysis (MSA)
• Experience with data analysis tools:
o JMP, Minitab, Python, or equivalent
• Comfort working with large inspection datasets to:
o Trend defect rates
o Support process improvements
o Drive inspection strategy decisions
SUMMARY
To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.
FUNCTIONS
-Conceives and designs, executes or evaluates, and interprets experimental strategies.
-Provides input to new processes to generate robust and reliable data.
-Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
-Designs, monitors or conducts experimental strategies with general guidance from supervisor.
-Provides data analysis and interpretation, and assesses impact of the data on the project.
-Keeps current in field of scientific expertise and areas relevant to their function.
-Monitors field of expertise, including literature and technology development, and communicates relevant observations.
-May introduce advanced scientific methods.
-Develops and implements new and novel protocols to address specific issues.
-May represent the department on project teams under supervision of a senior scientific staff member.
-May initiate productive collaborations within and outside of the department or company.
-Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
-Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
-Participates in external scientific community.
-May assume lead role in department-wide support efforts such as safety, recruiting and committees.
-May develop supervisory and mentoring skills.
-Develops and follows timelines for completing project team work.
EDUCATION
-Doctorate OR
-Master’s + 2 years of Scientific experience OR
-Bachelors + 4 years of Scientific experience.
COMPETENCIES/SKILLS
-Advanced scientific analysis and troubleshooting skills.Advanced laboratory work skills.
-Ability to motivate and/or supervise the activities of others.
-Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments.
-Must have demonstrated skills and competencies in the following areas: Verbal communication, Written communication including technical writing skills, negotiation and conflict resolution.Analytical problem solvingProject management.
-Ability to be flexible and manage change.
-Computer literacy (Windows environment: Word, Excel, Power Point).
-Skills requiring the application of scientific theory.
-Creative skills in the design and performance of scientific experiments and interpretation of results.
-Strong knowledge of cGMP
-Fully bilingual (English/Spanish).
Are there specific educational/software requirements needed?
-Doctorate OR
-Masters + 2 years of directly related experience OR
-Bachelors + 4 years of directly related experience OR
-Associates + 8 years of directly related experience OR
-High school/GED + 10 years of directly related experience
What attributes (i.e. - preferred qualifications) would make this candidate stand out?
Candidate must be proficient in SAP. Preferred if knowledgeable in VEEVA (CDOCS).
SUMMARY
Under minimal supervision provides Supply Chain work group supervision and technical expertise in support of successfully completing daily operations within scope of responsibility.
FUNCTIONS
- Ensures all work is completed with minimal disruption and in compliance with all cGMP guidelines and Client procedures.- Direct and coordinate daily activities of personnel responsible for material receipt, storage and transport.
- Ensures materials are received, stored and transported according to established performance standards and all applicable procedures and regulations.
- Interacts with internal and external regulatory agencies to ensure compliance with cGMP, DOT, OSHA requirements.
- Collaborate with other sites to maintain optimal flexibility for the storage of all materials and product.- Identify and oversee implementation of new and improved business and compliance systems and tools.
- Partner with key internal customer groups and/or external suppliers to ensure successful operations and performance targets are achieved.
- Responsible for business continuity programs for assigned areas.
- Participate on global functional teams to coordinate and improve the transportation and Logistics of material movement and storage across the Client Supply Chain.- Direct and coordinate daily activities of personnel responsible for developing and managing Product demand and forecasts.
- Organize and communicate on a regular basis the total demand and supply requirements to senior management.
- Coordinate the Master Production Schedule for Finished Goods and effectively communicate any impact created by, and to the supply plan.
- Manage the process of gathering, evaluating and feedback of global demand requirements.
- Provide and coordinate the development of business case scenarios that demonstrate the impact of current or proposed operations plans.
- Manage the preparation and communication of the Company wide Inventory Distribution Plan to achieve corporate goals of customer satisfaction and risk management.
- Develop and coordinate the long-range production requirements based on Marketing forecasts, product approval and release timelines, clinical requirements, SKU put-up information and business planning timelines estimates.
EDUCATION
-Doctorate OR
-Masters + 2 years of directly related experience OR
-Bachelors + 4 years of directly related experience OR
-Associates + 8 years of directly related experience OR
-High school/GED + 10 years of directly related experienceCOMPETENCIES/SKILLS
Must have well developed skills from Supervisor I level in addition to the following:
- Facilitation and presentation skills.
- Strong analytical problem solving skills.
- Strong technical writing skills.
- Strong project management skills.
- Change management skills.
- Ability to influence staff and effect change outside of area of responsibility.
- Initiate and lead cross-functional teams to resolve complex issues.
- Good decision making skills.
- Technical expert for function.
- Possess an understanding and appreciation of the Client Values and Leadership Attributes.
- While performing the duties of this job, the environment for the staff member is of an office atmosphere.- Computer terminals, telephones, and calculators are in use constantly.
- Assignments are received in task and objective oriented terms.
- Provides direction to subordinates using established policies and procedures.
- Work is reviewed upon completion for adequacy in meeting the task / objective.
- Administers policies and procedures that typically affect individual staff members within one or more functional work groups.
- Accomplishes tasks mainly through general supervision of nonexempt and experienced exempt employees.
- Monitors daily operations of a work group and actively assists, or provides direction to, subordinates as required.
- May perform ongoing operational tasks.
- Makes decisions regarding group operations.
- Erroneous decisions or recommendations or failure to achieve results might cause delays in program schedules and result in the allocation of more resources.
- Ensures tasks and projects are efficiently completed on schedule following established procedures and within budget.
- Majority of liaison is on internal basis with subordinates and supervisors at equivalent level or one level higher.- Regularly conducts briefings to management.
- Liaison normally involves specific phases of a project or operation.
- External contacts are regular and generally involve coordinating operational issues.
