Process Engineer III

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.

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.

• Oversee the design, installation, and optimization of complex manufacturing equipment.
• Provide technical leadership in troubleshooting and resolving equipment-related challenges.
• Lead cross-functional teams in the execution of equipment improvement projects.
• Collaborate with MTS and operations teams to introduce new technologies and processes.
• Mentor, train, and coach junior engineers, fostering professional development while driving an innovative and efficient mindset.
• Conduct risk assessments and implement process improvements to enhance efficiency and product quality.
• Participate in technology transfer activities and ensure successful integration of new processes.

Equipment Design and Optimization:

• Collaborate with the engineering team to design, specify, and optimize manufacturing equipment for pharmaceutical production.
• Conduct feasibility studies and provide technical input to ensure equipment meets project requirements.

Process Improvement:

• Identify opportunities for process optimization, efficiency gains, and cost reduction within the manufacturing environment.
• Implement and oversee continuous improvement initiatives to enhance equipment performance and reliability.

Equipment Qualification and Validation:

• Develop and execute equipment qualification protocols and validation procedures in compliance with industry regulations.
• Ensure equipment is qualified for intended use and meets regulatory standards.

Troubleshooting and Maintenance:

• Provide technical support for equipment-related issues, troubleshoot problems, and implement corrective actions.
• Collaborate with maintenance teams to develop and execute preventive maintenance plans for manufacturing equipment.

Documentation and Compliance:

• Generate and maintain accurate and comprehensive documentation related to equipment specifications, processes, and validation activities.
• Ensure adherence to regulatory requirements and quality standards in all equipment-related activities

Safety:

• Ensure contractor compliance with EH&S policies and procedures, including Hot Work and Lock Out Tag Out; uphold all safety procedures and safe practices.
• Inspect contractor's work to ensure that safe work practices and standard operating procedures are followed.

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

less than 1/4 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 1/4 to 1/2 of the day.

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.

EXPERIENCE

• 7+ years' experience with GMP, ISO, and/or an FDA-regulated environment is required.
• Proficiency in engineering principles and their application to pharmaceutical manufacturing processes
• Proven track record in managing complex engineering projects

EDUCATION

• Bachelor's degree in Engineering, Science, or a related field

QUALITIES

• Excellent project management skills
• In-depth knowledge of regulatory requirements and industry best practices
• Support initiatives to completion
• Excellent communication and interpersonal skills with the ability to work collaboratively across departments
• Ability to mentor junior engineers
• Detail oriented with problem-solving capabilities and able to implement innovative ideas
• Assertive, self-directed, and results-oriented
• Strong commitment to conducting PCI business according to the highest legal and ethical standards and to continually pursue excellence in the manufacturing and delivery of PCI products and services.
• Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities
• Must be able to work as a self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.

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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.