Validation Engineer

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Will need experience with:

1. Medical Device - preferably manufacturing over design
2. Process/Equipment Validation
3. Manufacturing
4. Project Management
5. Automation - Robotics & Manufacturing Cells
6. Sterilization Processes
7. Familiar with e-QMS systems such as QT9

POSITION SUMMARY:

Oversees and executes design and process validation activities to ensure regulatory compliance and high quality production processes and products consistent with established standards by performing the following duties personally.

ESSENTIAL FUNCTIONS (ACCOUNTABILITIES/RESPONSIBILITIES):

- Maintains quality assurance objectives complementary to corporate policies and goals.

- Participates in the Design and Development process.

- Leads and/or writes IQ, OQ, and PQ protocols for new and modified equipment and software.

- Leads and/or performs IQ, OQ, and PQ, activities for new and modified equipment and software.

- Leads and/or writes IQ, OQ, and PQ reports.

- Responsible for meeting meeting project due dates.

- Assists Engineering with process development and engineering trials.

- Ability to lead others in writing technical documentation clearly and informatively.

- Lead a validation team.

- Lead Corrective and Preventive Actions, Complaint Investigations, Non-Conformance investigations, and any required follow-up actions relative to Validation.

- Keeps management team abreast of significant issues or developments identified during quality assurance activities and actions being taken to improve the situation.

- Provides leadership to technical and administrative workers engaged in quality assurance activities related to validation activities.

- Maintains a working knowledge of company quality assurance documents, instructions, and procedures.

- Leads quality management teams within the organization.

- Responsible for training personnel in processes related to validation activities

Leader in process and product improvement activities related to validation activities

QUALIFICATIONS:

Experience

- Three years' experience in validation activities in a medical device or pharmaceutical environment.

Education

- Bachelor's degree or higher, preferably in a scientific field.

General Skills/Competencies/Specialized Knowledge

- Language Ability - Ability to read and interpret quality assurance and company procedures. Ability to communicate clearly and concisely, both verbally and in writing. Ability to effectively present information and respond to questions from employees, supervisors, managers, and executive staff.

- Math Ability - Ability to apply concepts such as fractions, percentages, ratios, and proportions.

- Reasoning Ability - Ability to define problems, collect data, establish facts, and draw valid conclusions.

- Ability to perform statistical analysis.

- Computer Skills - To perform this job successfully, an individual should be familiar with Microsoft Word, Excel, and Outlook or similar e-mail program. Individual should also be familiar with using a statistical program such as MiniTab.

- Certificates and Licenses - No certifications required. ASQ certification preferred.

- Supervisory Responsibilities - This position has no supervisory requirements.

- Attendance and Punctuality - Is consistently at work and on time; ensures work responsibilities are covered when absent, arrives at meeting and appointments on time and prepared.

- Dependability - Follows instructions; responds to management direction; takes responsibilities for own actions; keeps commitments; completes tasks on time or notifies appropriate management.

- Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.

- Interpersonal - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to other's ideas and tries new things.

- Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Participates in meetings.

- Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Presents numerical data effectively; Able to read and interpret written information. Writing ability is essential to this position.

- Team Work - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed.

- Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

- Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values.

- Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

- Initiative - Volunteers readily; Seeks increased responsibilities; Asks for and offers help when needed.

- Innovation - Generates suggestions for improving work;

- Motivation - Demonstrates persistence and overcomes obstacles.

- Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently.

- Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.

- Quality - Demonstrates accuracy and thoroughness in work performed; looks for ways to improve and promote quality; monitors work to ensure quality.

- Quantity - Meets productivity standards; completes work in a timely manner; strives to increase productivity; works quickly and efficiently.

- Safety and Security - Observes safety and security protocols; reports potentially unsafe conditions; uses equipment and materials properly.

TRAVEL REQUIREMENTS/WORK ENVIRONMENT AND PHYSICAL DEMANDS:

Travel

Less than 30% domestic/International travel

Work Environment and Physical Demands

- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Specific vision abilities required by this job include Close vision.