Production Engineer

PharmEng is a leading Pharmaceutical and Biopharmaceutical Consulting company committed to delivering innovative solutions for our industry's challenges. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. We are seeking a highly skilled and motivated Production Engineer System owner for a full-time role.

Job Description:

The production Engineer and system Owner serve as the technical lead and support the specification, installation, utilization, qualification, and improvement of equipment used for the assigned manufacturing area

Responsibilities:

• Understand the functionality and operation of the equipment.

• Responsible for the current and future design of the equipment/system.

• Accountable for keeping technology current.

• Identifies and implements best-demonstrated practices (via Communities of Practice and/or other methods).

• Owns SOP/work instructions for operating system/equipment.

• Develop training and troubleshooting guides.

• Ensure the technical reliability as well as the safety of production facilities in the assigned manufacturing department. Work to improve equipment reliability as measured by Operational Equipment Effectiveness (OEE).

• Evaluate and update PMs to keep system performance optimal.

• Implements and monitors predictive maintenance of the system to prevent breakdowns of the system.

• Implements and monitors TPM to ensure the system stays in like-new condition.

• Works collaboratively with multiple functional areas such as EHS, Quality, Process Engineering, and Manufacturing.

• Ensures the system can be operated safely by the operators.

• Minimizes quality deviations and discards associated with the system.

• Maximizes efficiency/OEE, yield, output, & capacity of the system.

• Updates maintenance and calibration plans by collaborating with the expert groups.

• Providing data analysis to identify technical changes and replacement investments based on de- bottlenecking and long-term, obsolescence strategies.

• Prevents obsolesce of system parts and components that can impact safety, quality, and reliability.

• Oversees reconditioning of the equipment to restore it to like-new condition.

• Performs upgrades to improve safety, and operational performance, and extend operational life.

• Develops end-of-life replacement plans for the system to ensure reliable supply to our patients.

• Collaborates with local and global partners to develop an asset management plan that includes capital requests.

• Ensure equipment and processes are compliant with government regulations. Acts as equipment SME during internal or external Regulatory inspections.

• Foster a culture of continuous improvement through employee selection, training, and mentoring while focusing on operational efficiency and the elimination of "non-value added" activities.

• Complies with  Health and Safety mandates and OSHA requirements.

• Completes any other duties/responsibilities assigned by senior management.

Qualifications:

• Requires a bachelor's degree in Mechanical, Chemical or Manufacturing Engineering.

• 4 years of relevant experience and a BS

• 2 years of relevant experience and an MS.

• Strong verbal, technical writing and interpersonal skills are required. Strong communication skills with customers, design teams, contractors, and management

• Action oriented skills; ability to learn on the fly

• Good problem solving, technical learning, time management and prioritizing skills

• Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility. Prior experience in the pharmaceutical industry is preferred.

• Proficient knowledge of Good Manufacturing Practices (GMPs)

• Audit and Investigation Skills, Report Writing Skills.

• Proficiency in Microsoft Office applications.

PharmEng is an equal-opportunity employer and welcomes candidates of all backgrounds to apply.