Job Description

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Validation Engineer I evaluates and performs specified validations leading to the accurate and reliable validation of products, processes, equipment, facilities, and systems; assists/performs development of studies/cycles for new processes; helps troubleshoot product problems related to validation; performs testing and documents results for review by site, corporate and government review. Further responsible for providing supporting protocol rationales/justifications for the chosen validation methodology/approach.

Participates in programs to achieve departmental objectives. Records and reports results. Notes unusual results and notifies management for evaluation. Assists with writing validation documents.

In partnership with the site leaders, sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

Job Description

Validation Protocols

• Generates validation protocols, and summarizes studies to ensure consistency of data production and compliance with manufacturer and Par Sterile Product’s specifications, with current Good Manufacturing Practices, and national standards
• Responsible for confirming all communicated validation plans to applicable management
• Provides technical assistance in the form of rationales or validation studies to support acceptability of the manufacture of products at Par Sterile Products
• Assists with development of validation protocols, performs testing and writes validation reports for various equipment/processes pertaining to the manufacturing area.
• Helps to determine process capability of new equipment though execution of approved protocols and assures that defined parameters are incorporated into respective operating procedures
• Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of processes and equipment.
• Troubleshoots and resolves issues as needed

50%

Production Process

Qualification

• Responsible for the performance qualification of production processes, and writes process validation protocols and final report packages
• Generates, executes and summaries Product Process Qualification for the entire scope of the production processes

25%

Project Management

• Provides validation input at team meetings for various projects
• Capable of managing multiple projects while adhering to project deadlines
• Performs special projects as assigned by department management

15%

Deviation Investigation

• Conducts deviation investigations
• Evaluates equipment or process problems and designs testing to determine possible causes or solutions.

10%

Cross-Functional Activities

• Establish and maintain effective cross functional relationships

Continuous

Reports

• Analyze data and generate reports

Continuous

Standard Operating Procedures

• Adheres to all company and cGMP procedures, along with safety regulations within the plant.

Continuous

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

• Bachelor of Science in Engineering or Science discipline preferred
• Zero (0) to three (3) years of combined experience in pharmaceutical (i.e. Validation/QA or R&D), medical device, biotechnology industries or equivalent combination of education and experience

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Proficient in Microsoft Word, Excel, Power Point, Project and other software relevant to the performance of the Job

Skills & Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

• 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.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
• Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
• Teamwork - 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; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
• Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; Builds a diverse workforce.
• 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; Benefits organization through outside activities; Supports affirmative action and respects diversity.
• 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; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
• Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
• Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.

Physical Requirements

• Stand
• Walk
• Sit
• Lift
• Talk or hear
• Work Environment
• Wet or Humid
• Work near moving mechanical parts
• Fumes or airborne particles

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

EEO Statement:

We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

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