Manager Validation Engineer Salary range is: $65,000 to $85,000 dependant on skills and experience.

This Position's Location is: Mount Prospect, IL; OR Bristol, PA; OR Allentown, PA Position Summary: The Manager, Validation Engineer is responsible for writing protocols, determining parameters, coordinating and performing equipment, process and material validations for Operations.

This includes directing and supporting all testing, engineering studies, validations, change control, impact analysis, regression testing, re-validation/re-qualification and development of all validation methodology.

Additionally, this position will lead practical process improvement (PPI) and Lean PPI initiatives in order to achieve efficiency gains and process improvements while sustaining compliancy throughout the North American sites.

Basic Minimum Qualifications (BMQ): To perform this job successfully, the individual must be able to perform each essential duty satisfactorily.

The requirements below are representative of the knowledge, skill or ability required.

6+ years minimum in managing an equipment/process validation program/organization in a pharmaceutical or medical device industry with direct reports 5+ years strong knowledge of cGMPs, QSRs and/or ISO 4+ years working in a FDA- regulated environment is required.

5+ years superior problem solving skills Education/ Experience (BMQ): BS in Engineering (Mechanical, Industrial, Electrical, Manufacturing, Process or Quality discipline) or BA/BS in the Sciences from a four year accredited college or university.

Add’l preferences: Hands-on experience in pharmaceutical bottle line and blister line equipment/process validation a plus.

Certificates and/ or Licenses (BMQ): Certification/affiliation with engineering or quality engineering disciplines.

PMP PMI certification preferred.

Lean Six Sigma Green Belt, Black Belt or Lean Certified preferred.

Add’l Must have a valid driver’s license and current passport Supervisory Responsibility: Manage Validation Associate(s) in home site.

Individual must be a self starter.

Experience working in a matrix organization.

Internal and External Contacts: A high degree of interaction with internal and external contacts is required at all levels of the organization.

Frequent interactions are expected with Production/Operations, Quality, Engineering, Client Services and Logistics /Distribution.

Periodic contact is required with clients in support of FCS Validation Program, projects, presentations, tours and capabilities.

Ability and/or Skills (BMQ): The individual in this position must possess the following skills and/or abilities to be effective in the role: · Strong leadership skills with a good customer service oriented background.

· Excellent verbal, concise written communication skills.

· Forward thinking skills for potential compliance related issues.

· A strong and rational decision maker based with constant balances between quality and business needs.

· Draw conclusions and communicate based on analytical reasoning, objective evidence or supporting data.

· Ability to effectively interact with a diverse range of individuals including external customers and operate and/or project a strong professional image.

· Strong ability to start and drive tasks/projects to closure in a timely fashion.

· Strong training and mentoring skills.

· Strong background in engineering and the ability to relate engineering principles to the operations.

· Develop and conduct training as relates to new equipment, systems and processes· Process improvement champion and performance management· Collaboration, teamwork and influencing· Prioritization and decision-making· Effective information presentation and query response· Proficiency in personal computer applications (eg Microsoft Word, Excel, PowerPoint, Access, Outlook, Project, Visio and quality system software) Work Schedule: 8:00 AM to 5:00 PM core hours, additional hours as required.

>30 % travel Other Factors: No severe physical demands.

Some walking in warehouse and production area required.

Education: BachelorsJob Level: Experienced

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