Operations Training Engineer

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Operations Training Engineer

Department/Group: Operations

Location: Assembly

Reports to: Rick West

FLSA Status: Exempt

Prepared By: Rick West

Approved By: Angella Sutthiwan

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 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 in the most efficient and effective way.

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.

• Will be responsible for overseeing the creation and revising of production and maintenance work
  
  

instructions, job aides and one point lessons that fully document expectations that comply with all

applicable regulations including but not limited to cGMP, OSHA, DEA and other regulatory requirements.

• Work with Engineering when new equipment / processes are being purchased / developed to capture the
  
  

best practice for operating the equipment. This will include attending FAT’s and SAT’s, being present for

trial work. Reading manuals, contacting equipment vendors to ensure equipment capabilities and operating

expectations are defined and captured on the OJT document.

• This position will direct on the Process Trainers and their work. This position will coordinate, direct and
  
  

prioritize the activities of the Operations training team working collaboratively with the Supervisors and

Managers. This position will recruit and direct their own team but also influence the selection of Process

Trainers (OJT) Trainers that report to the Production Supervisor.

• The position will be responsible for helping to maintain the integrity of the certification process by working
  
  

with Operations Training Leads, the Process Trainers, Supervisors and Team Leads to maintain the proper

certification standards.

• Will oversee the development of On the Job training programs and curriculums for production and
  
  

maintenance. This includes new hire on-boarding as well as the continuation of training for all existing

maintenance and operations personnel.

• Will work with Operations and Maintenance Managers on creating certification criteria that are objective in
  
  

nature, resulting in only proficient people being certified to perform job duties.

• 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.

• Will work with other departments as required. 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. Also will need to work with

Business Units to assess training impact as revisions to batch records are made.

• Will work with Operations Training Leads, Process (OJT) Trainers, Managers and Supervisors to solicit
  
  

feedback on training effectiveness and to make improvements based upon this feedback.

• Will own the departmental on-boarding process for all Operations new hires including Agency training.
• Will work with Directors of Operations to create appropriate training metrics to measure training execution,
  
  

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overall health of the department and training hours and dollars

• Will on an as needed basis participate in Safety and Quality RITs and work to address any training
  
  

opportunities.

• Will join in continuous improvement efforts to help sustain gains with adopting standard work and working
  
  

to certify people to these new standards by updating OJT certification checklists

• 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. Will also work with the Quality Training

Department when creating new or updating existing operations and maintenance curricula.

• Will work to consolidate and maintain the proper number of training documents with the goal being to
  
  

deliver the required information in the most efficient and cost effective way possible.

• This position will require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GDP policies, procedures, rules.
• Attendance to work is an essential function of this position
• Performs other duties as assigned by Manager/Supervisor.
  
  

Supervisory Responsibilities: Carries out supervisory responsibilities in accordance with the organizations policies

and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and

directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving

problems.

• Supervises 1-10 employees
  
  

Special Demands: The physical demands described here are representative of those that must be met by an

employee to successfully perform the essential functions of this job. The employee must be physically capable to

perform the duties listed below with or without reasonable accommodations which may be made to enable

Individuals With Disabilities To Perform The Essential Functions

• Stationary Position: Under a 1/4 of the day.
• Move, Traverse: Up to 1/4 of the day.
• Operate, activate, use, prepare, inspect, or place: None
• Install, place, adjust, apply, measure, use, or signal: None.
• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): Up to 1/4 of the day.
• Communicate or exchange information: From 1/2 to 3/4 of the day.
• Detect, distinguish, or determine: Up to 1/4 of the day.
  
  

On an average day, the individual can expect to move and/or transport up to 10 pounds

from 3/4 of the day and up.

This position may have the following special vision requirements.

☐ Close Vision ☐ Distance Vision ☐ Color Vision ☐ Peripheral Vision ☐ Depth Perception

☐ Ability to focus ☒ No Special Vision Requirements

Work Environment: The work environment characteristics described here are representative of those an employee

encounters while performing the essential functions of this job. Reasonable accommodations may be made to

Enable Individuals With Disabilities To Perform The Essential Functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for

various lengths of time.

• Work is primarily performed at a desk and/or in an office environment. for 1/2 to 3/4 of the day.
• Work is performed in areas with moderate risk or discomfort that may require special safety
  
  

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precautions, such as wearing protective clothing or gear for up to 1/4 of the day.

• Work near moving mechanical parts for up to 1/4 of the day.
  
  

The noise level in the work environment is typically, moderate.

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 the

Required

essential functions.

• Bachelor's Degree in a related field and/or 1-3 years related experience and/or training.
• College Level Mathematical Skills
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various
  
  

computer programs.

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels
  
  

pertinent to professional needs.

• 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

• Ability to effectively present information to various people as the job requires.
• Ability to follow instructions and respond to management direction.
• Ability to identify and resolve problems in a timely manner.
• Ability to work independently and/or as part of a team.
• Training Within Industry certifications preferred and will be required as part of the job.
  
  

Lean SixSigma Greenbelt preferred.

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.