Operations Training Engineer Job at PCI Pharma Services
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Objective:
This position is responsible for the creation and maintenance of documented best practices within the commercial production and maintenance departments. This position will develop, implement and maintain appropriate skills-based training and competency-based certification process that aligns with performing jobs in strict compliance with the approved documented best practice, resulting in consistently exceptional performance regarding safety, quality, compliance, cost, and delivery. This position will work closely with the site Quality Training Department to collaborate on delivering training most efficiently and effectively.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
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Will be responsible for creating and revising production and maintenance work instructions, job aids, and one-point lessons that fully document expectations that comply with all applicable regulations including but not limited to cGMP, OSHA, DE,A and other regulatory requirements.
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This position will direction-the-job training specialist and their work.
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This position will coordinate, direct and prioritize the activities of the Operations training team working collaboratively with the Supervisors and Managers.
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This position will recruit and direct their team but also influence the selection of OJT Trainers that report to the Production Supervisor.
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The position will be responsible for helping to maintain the integrity of the certification process by working with the OJT Specialist, Supervisors and Team Leads to maintain the proper certification standards.
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Will oversee the development of On the Job training programs and curriculums for production and maintenance.
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This includes new hire onboarding as well as the continuation of training for all existing maintenance and operations personnel.
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Will work with Operations and Maintenance Managers on creating certification criteria that are objective resulting in only proficient people being certified to perform job duties.
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Will oversee the maintenance of the training matrix and work with Supervisors and Managers on highlighting gaps that need to be addressed in training depth but also in performance as people work towards achieving proficiency.
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Will work with other departments as required.
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Examples include working with the safety team to make sure all safety aspects of a job are adequately covered and working with Engineering or Maintenance as new equipment is brought in and/or revised and the impact on training.
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Also will need to work with Business Units to assess training impact as revisions to batch records are made.
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Will work with OJT Specialists, OJT Trainers, Managers, Specialists, and supervisors to solicit feedback on training effectiveness and to make improvements based on this feedback.
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Will own the departmental on-boarding process for all Operations new hires including Agency training.
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Will work with Directors of Operations to create appropriate training metrics to measure training execution, the ll health of the department and t, and raining hours and dollars .
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ill on an as needs-needed participate in Safety and Quality RITs and work to address any training opportunities.
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Will join in continuous improvement efforts to help sustain gains with abying standard work and working to certify people to these new standards by updating OJT certification checklists.
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Will work specifically with the training department to make sure OJT trainers are adequately trained and will also work with training to address compliance gaps.
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Will also work with the Quality Training Department when creating new or updating existing operations and maintenance curricula.
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Will work to consolidate and maintain the proper number of training documents with the goal being to delivering the required information in the most efficient and cost effort-effect visible.
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This position will require overtime and/or weekend work.
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Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
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and Attendance to work is an essential function of this position.
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Performs other duties as assigned by Manager/Supervisor.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Required:
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Bachelor's Degree in a related field and/or 1-3 years of related experience and/or training.
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College Level Mathematical Skills
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Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
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Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
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High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
Preferred:
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Ability to effectively present information to various people as the job requires.
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Ability to follow instructions and respond to management direction.
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Ability to identify and resolve problems promptly.
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Ability to work independently and/or as part of a team.
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If other, please type here.
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If other, please type here.
Join us and be part of building the bridge between life changing therapies and patients.
Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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