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Training Coordinator - Validation Job
Date: Mar 3, 2010
Location: United States
Training Coordinator - Validation-MAN000440
Description
Meet the new Merck. A stronger pipeline. More products to help people in more ways. More passionate than ever about what matters to our customers.
Merck and Schering-Plough are now one company. We recently merged to create a stronger, more diverse and more truly global company. This not only benefits our company and our shareholders, but it also benefits the millions of people around the world who rely on our products and expect us to continue to deliver exceptional value.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
Merck's Biological Sterile Validation Department (BSV), located in West Point, PA, is currently seeking a Training Coordinator. BSV's responsibilities include providing documented evidence that processes are consistent and reliable through challenges against pre-established criteria for all vaccines (worldwide) and sterile pharmaceuticals (West Point).
Responsibilities include but are not limited to:
* Responsible for the development and the delivery of training to ~150 direct and contractor/consultant staff members of the Merck, West Point MMD Validation Group
(GVDMS-BSV).
* Act as a resource to various validation teams in achieving their training goals, specifically SOP revisions and updates.
* Develop hands on training courses prior to actual live field work. Train other trainers (SMEs) representing the various platform areas.
* Work with managers/employees/teams in identifying skill gaps to develop and implement individual and group training programs encompassing regulatory, technical, computer, business and leadership skills.
* Responsible for staying abreast of new and changing technology, procedures, and management practices to maintain a highly skilled workforce.
* Work with other site trainers to create and deliver training programs specific to individual groups background and knowledge.
* Supervise and direct project activities. Create and Update "New Employee" manuals and records as needed.
* Update Team intranet website with Training updates & information.
* Prepare staff and follow up on training for Regulatory audit preparation and compliance.
* Validation Group (BSV) System Administrator for the following programs: MELS, TIS, TIS Express, TARS, Cognos, Manager Access and Primivera and/or IsoTrain.
* Develop and/or Update Trainings for: SIP/CIP, CTU, Thermal Equipment (TCs, Flukes, etc).
* Required to attend cGMP and Business Training as Required.
Qualifications
Educational requirements:
* BS/MS in Chemical or Mechanical Engineering or Organizational Development, Industrial/Organizational Psychology, Human Resources.
* Industrial training/supervisory experience may be substituted in lieu of formal Organizational Development or Industrial Psychology degree.
Required:
* At least 4 years of experience in a pharmaceutical environment.
* At least 2 years of experience in a training role.
* Knowledge of adult learning theories, needs assessments and competency based training.
* Effective group facilitation and presentation skills.
* Experience in program development & delivery, training documentation & development, script writing, and use of audio-visual equipment.
* In depth knowledge cGMPs, validation, quality, technical and team skills required to perform sitewide tasks.
* Excellent teamwork and leadership skills, a strong quality orientation, good work ethics, and multi-tasking capability. Ideal candidate will be analytical, creative, innovative, confident and influential.
* Ability to lead individuals or groups without direct reporting relationships.
Preferred:
* Experience in the application and teaching of Validation related topics.
* Technical Scientist and/or Engineer that can conduct Validation Studies and is proficient in at least 2 of the following Validation fields: Temperature Mapping (CTU), Process, Sterilization (Dry, Steam, Chemical, Radiation), Cleaning, Methods, Cold Chain, Filters, Container Closure Integrity, Leachanbles/Extractables, Automation (CSV)
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
merck.com/careers to create a profile and your resume for requisition # MAN000440.
Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully:
Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Primary Location
:United States
Employee Status
:Regular
Number of Openings
:1
Description
Meet the new Merck. A stronger pipeline. More products to help people in more ways. More passionate than ever about what matters to our customers.
Merck and Schering-Plough are now one company. We recently merged to create a stronger, more diverse and more truly global company. This not only benefits our company and our shareholders, but it also benefits the millions of people around the world who rely on our products and expect us to continue to deliver exceptional value.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
Merck's Biological Sterile Validation Department (BSV), located in West Point, PA, is currently seeking a Training Coordinator. BSV's responsibilities include providing documented evidence that processes are consistent and reliable through challenges against pre-established criteria for all vaccines (worldwide) and sterile pharmaceuticals (West Point).
Responsibilities include but are not limited to:
* Responsible for the development and the delivery of training to ~150 direct and contractor/consultant staff members of the Merck, West Point MMD Validation Group
(GVDMS-BSV).
* Act as a resource to various validation teams in achieving their training goals, specifically SOP revisions and updates.
* Develop hands on training courses prior to actual live field work. Train other trainers (SMEs) representing the various platform areas.
* Work with managers/employees/teams in identifying skill gaps to develop and implement individual and group training programs encompassing regulatory, technical, computer, business and leadership skills.
* Responsible for staying abreast of new and changing technology, procedures, and management practices to maintain a highly skilled workforce.
* Work with other site trainers to create and deliver training programs specific to individual groups background and knowledge.
* Supervise and direct project activities. Create and Update "New Employee" manuals and records as needed.
* Update Team intranet website with Training updates & information.
* Prepare staff and follow up on training for Regulatory audit preparation and compliance.
* Validation Group (BSV) System Administrator for the following programs: MELS, TIS, TIS Express, TARS, Cognos, Manager Access and Primivera and/or IsoTrain.
* Develop and/or Update Trainings for: SIP/CIP, CTU, Thermal Equipment (TCs, Flukes, etc).
* Required to attend cGMP and Business Training as Required.
Qualifications
Educational requirements:
* BS/MS in Chemical or Mechanical Engineering or Organizational Development, Industrial/Organizational Psychology, Human Resources.
* Industrial training/supervisory experience may be substituted in lieu of formal Organizational Development or Industrial Psychology degree.
Required:
* At least 4 years of experience in a pharmaceutical environment.
* At least 2 years of experience in a training role.
* Knowledge of adult learning theories, needs assessments and competency based training.
* Effective group facilitation and presentation skills.
* Experience in program development & delivery, training documentation & development, script writing, and use of audio-visual equipment.
* In depth knowledge cGMPs, validation, quality, technical and team skills required to perform sitewide tasks.
* Excellent teamwork and leadership skills, a strong quality orientation, good work ethics, and multi-tasking capability. Ideal candidate will be analytical, creative, innovative, confident and influential.
* Ability to lead individuals or groups without direct reporting relationships.
Preferred:
* Experience in the application and teaching of Validation related topics.
* Technical Scientist and/or Engineer that can conduct Validation Studies and is proficient in at least 2 of the following Validation fields: Temperature Mapping (CTU), Process, Sterilization (Dry, Steam, Chemical, Radiation), Cleaning, Methods, Cold Chain, Filters, Container Closure Integrity, Leachanbles/Extractables, Automation (CSV)
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
merck.com/careers to create a profile and your resume for requisition # MAN000440.
Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully:
Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Primary Location
:United States
Employee Status
:Regular
Number of Openings
:1
Job Segments: Business Intelligence, C#, Education
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