Our Mission: At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Who we are: STERIS is a growing provider of infection prevention and other procedural products and services through our family of wholly owned subsidiaries.
Manage the validation activities required to comply with current regulations. Drafts, reviews, approves and facilitates the completion of validation protocols. Executes or manages execution of validation protocols and reports. Facilitates resolution of deficiencies that prevent successful validation of processes, conducts DOE’s, controlled engineering experiments, etc. Works closely with R & D to release projects from R & D to Manufacturing. Responsible for multi-site projects including work by self as well as directing the activities of others. The position may include direct reports based on business conditions and dimensions of projects or needs to directly oversee the work of others. Oversee the project management and validation activities of supplier second sourcing or other supplier validation activities.
1.Write process equipment validations, which would include (IQ, OQ, PQ) and the Final Report.
2.Work closely with Engineering and Quality Systems to complete the process validation of manufacturing equipment.
3.Ensure validation activities are conducted in compliance with applicable regulations as well as STERIS Quality System and Safety policies and protocols.(i.e. change controls).
4.Conduct DOE’s.(Design of Experiments)
5.Ensure risk management tools are employed and accurate (hFMEA, pFMEA).
6.Coordinate Engineering and Manufacturing staff to support the required validation.
7.Ensure that transfers of R & D projects meet equipment validation requirements.
8.Initiate and evaluate all available technical data in order to develop conclusions derived from studies undertaken. Provide analysis, evaluation, and interpretation of data.
9.Ensure compilation and storage of critical validation history documentation
10.Utilize appropriate project management skills and tools to meet timelines and provide progress updates to management.
11.Lead assigned staff in carrying out their duties as required.
12.Periodically monitor existing validations and update/modify as conditions change.
13.Manage supplier validation and second sourcing projects in support of Strategic Sourcing and Purchasing.
14.May directly supervise the work of others and/or have direct reports as situations may require.
- Execute qualification protocols as required and assists in the development of training materials for qualification activities.
- Assistance with and preparation for compliance audits as needed.
- Other duties as assigned which may include process development, project management, process optimization projects or other duties to optimize the plant operations.
Duties - cont'd
Bachelor's Degree in Engineering General
- Demonstrated knowledge and experience in process/equipment Validation. Minimum 8 years required.
- Medical device industry experience strongly preferred.
- Requires excellent interpersonal skills and strong team orientation.
- Strong understanding of the validation process within a regulated environment.
- Ability to negotiate, lead and manages validation strategies.
- Requires excellent analytical, oral, and written communication skills.
- Proven record of facilitating project teams to achieve target goals and delivery timelines.
- Must have thorough knowledge and understanding of and a proven track record of successful project completions and validation protocols in a cGMPs, FDA or ISO 13485 environment or similar regulation.
- Must be proficient with MS Office Suite, Excel and statistical analysis software.
STERIS plc is a $2B, publicly traded (NYSE: STE) organization with more than 14,000 employees worldwide. We are dedicated to providing our Customers with innovative infection prevention, decontamination, and health science technologies, products and services.
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
We assure you that your opportunity for employment depends solely on your qualifications. Those applicants requiring reasonable accommodation(s) to complete this application and/or during the interview process should notify a representative of the Human Resources department at 440-392-7047.