Experience Inc. Jobs

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 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. ​

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 revision of instruments controls and vision (IC&V) 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.

.

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 maintenance, Instruments controls and vision (IC&V) department. This includes new hire on-boarding as well as the continuation of training for all existing maintenance and IC&V 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 oversee the departmental on-boarding process for all maintenance and IC&V new hires including Agency training.​

​​Will work with Directors of Operations to create appropriate training metrics to measure training execution, 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 perform frequent audits to ensure OJT trainers are adequately trained and address compliance gaps. Will work with the Department SMEs and Management when creating new or updating existing 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.

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 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 essential functions.

Required:

• ​​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.

#LI-DT1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled