Operations Process Engineer

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.

Operations Process Engineer

Summary of Objective:
This position will work to continuously improve processes and systems that ultimately lead to improved profitability to the company. Using all available Engineering, Lean and Six Sigma tools, this position will work independently and cross functionally to drive out waste and reduce process variability 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. 1. Schedule and lead continuous improvement initiatives with the necessary subject matter experts (SME). 2. Interact with upper management to communicate status of continuous improvement initiatives. Ensure concise communication of status as well as any areas where barriers exist. 3. Gather and analyze data using the operations data collection systems, including but not limited to: Overall Equipment Efficiency (OEE), uptime, scrap, margin, staffing, quality, capacity, safety and direct labor cost per unit to facilitate decision-making as well as identify and prioritize initiatives. This will require ownership of the data collection systems to insure the purity and consistency of the source. 4. Design ways to improve processes via implementation of lean and continuous improvement efforts. Serve as coach for the applicable process owners to drive overall process changes and sustainability. 5. Drive sustainability of projects through key metrics that tie to overall facility KPI’s. Utilize Pareto analysis to identify areas for opportunity and prioritization. 6. Partner with Site Leadership to identify and lead lean deployment. Areas of focus will include but not be limited to Value Stream Mapping, Continuous Flow, Kaizen, 5S, PDCA, Root Cause Analysis, Standard Work, Visual Factory and Gemba Walks. 7. This position will help create documented best practices. This includes writing and creating SOP’s, on the job training checklists for certification purposes and reviewing and approving batch records to assist in sustaining gains. This could include conducting group training on all shifts. 8. This position will require auditing of all new processes as the project transitions from preparation to execution. This will require coaching and partnering with cross functional teams to insure the process as it was prepared is running at or above quoted rate less than the quoted scrap during and following the validation process. 9. This position will require auditing of existing processes to identify waste opportunities and coach on the spot to maximize efficiencies. 10. This position may require overtime and/or weekend work. 11. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. 12. Attendance to work is an essential function of this position 13. Performs other duties as assigned by Manager/Supervisor. 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: From 1/2 to 3/4 of the day. - Move, Traverse: From 1/4 to 1/2 of the day.
2
- Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day. - Install, place, adjust, apply, measure, use, or signal: None. - Ascend/Descend or Work Atop: None. - Position self (to) or Move (about or to): From 1/4 to 1/2 of the day. - Communicate or exchange information: 3/4 of the day and up. - Detect, distinguish, or determine: From 1/4 to 1/2 of the day. On an average day, the individual can expect to move and/or transport up to 10 pounds between 1/4 and 1/2 of the day. 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 up to 1/4 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 1/4 to 1/2 of the day. ➢ Work near moving mechanical parts for 1/2 to 3/4 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 1-5 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. - Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables. - Training in Lean and Six Sigma Preferred: - Ability to effectively present information to various people as the job requires. - Ability to work independently and/or part of a team. - Ability to display original thinking and creativity. - Ability to set and achieve challenging goals. - Black or Green Belt and Lean Certifications preferred - Experience in JD Edwards, OEE software (MES) and Controlled Documents software (Pilgrim) - Previous leadership, supervisor or management experience desired

#KI-KH1

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.

At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.