Director of Process Engineering

4 weeks ago

Philadelphia, United States PCI Pharma Services Full time

Summary of Objective:

The main functions of a Director of Process Engineering are focused on 6 key activities of the plant for all value streams: Lead the team of Process Engineers with clear goals and vision to support the Drug Device Combination (DDC) operational unit. Manage the team staffing levels and budget allocation to ensure the DDC operational unit is supported appropriately. Guide the process engineers when providing plant floor support such as CAPA ownership, equipment troubleshooting, and technical training of operations staff. Provide leadership and guidance for product launches that includes customer meetings and project tracking. Drive the continuous improvement efforts of the operational unit in partnership with the site CI Manager and other department leaders. Provide input and information to the site capital equipment plan.


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.

  • Ensure a safe working environment through example and prioritizing safety actions and behaviors among the team.
  • Lead the DDC Process Engineering team. Establish clear goals and objectives for engineers that align to the department, plant, and corporate goals.
  • Monitor current and projected workload to ensure proper staffing levels that align with the site budget.
  • Lead and guide the team of process engineers through standard root cause analysis for device assembly, labeling, & packaging equipment and process inefficiencies.
  • Track and drive the team to complete all Quality Management System (QMS) tasks (CAPAs, DNs, & Change Controls) to timely and thorough completion.
  • Provide when needed and coach process engineers in the execution of technical training of device assembly, labeling, & packaging equipment and processes for the operations staff.
  • Monitor and track progress of product launches and pay special attention to actions owned by engineering.
  • Provide support and coaching to keep DDC product launches on target, including the explanation of PCI device capabilities in customer meetings & leading technical solution brainstorming sessions.
  • Partner with the Continuous Improvement Manager to identify and eliminate waste from processes with emphasis in improving quality (scrap & defects), reducing lead time, increasing capacity, & reducing cost.
  • Partner with the DDC Director of Operations to ensure that processes run efficiently, allowing the site to meet its commitments to customers in a safe manner with high quality, on time delivery, & on budget.
  • Partner with Quality leaders to ensure effective CAPAs are identified and implemented in a timely and cost-effective manner.
  • Partner with other Engineering leaders to ensure engineering systems and processes are maintained and improved including, capital expenditure planning, equipment commissioning, & equipment reliability.
  • Apply Lean Six Sigma tools and coach engineers to identify and solve complex problems.
  • This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
  • Attendance to work is an essential function of this position. 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 the essential functions.


Required:

  • Bacheor's Degree in a related field and/or 7-10 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.
  • High Standard of Report Writing

Preferred:

  • Master's Degree (M.A.) in related field and/or 5+ years related experience or training.
  • Ability to effectively present information to various people as the job requires.
  • Ability to identify and resolve problems in a timely manner.
  • Ability to display a willingness to make decisions.
  • Six Sigma Black Belt certified.
  • Implementation of lean manufacturing techniques to eliminate waste.
  • Medical device assembly experience.
  • Show success in managing people.
  • Ability to work independently and as part of a team.
  • Ability to display original thinking and creativity.
  • Ability to display excellent time management skills.
  • Ability to set and achieve challenging goals.

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