Plant Engineer II

LSNE Contract Manufacturing; Bedford (NH); On-site; USD 90,000 - 130,000; Full time

Job summary

PCI Pharma Services in Bedford, NH is seeking a Plant Engineer II to optimize and maintain manufacturing equipment for pharmaceutical fill-finish operations. You will collaborate with cross-functional teams to support continuous improvement and ensure equipment reliability.

The role requires designing and qualifying equipment, implementing preventive maintenance, and mentoring junior engineers while upholding regulatory standards in a fast-paced environment.

Qualifications

• 4+ years in GMP/ISO or FDA-regulated pharma environment.
• Experience with equipment design, installation, and validation.
• Strong documentation and compliance skills.
• Excellent cross-functional collaboration abilities.

Responsibilities

• Lead the design and specification of manufacturing equipment, ensuring compliance with project requirements.
• Coordinate the installation, commissioning, and validation of new equipment.
• Troubleshoot and resolve equipment-related issues, working closely with cross-functional teams.
• Develop and implement preventive maintenance programs for critical equipment.
• Contribute to continuous improvement of manufacturing processes through equipment upgrades and modifications.
• Mentor and guide entry-level engineers in equipment-related tasks.

Skills

GMP knowledge

Regulatory compliance

Equipment design

Troubleshooting

Project management

Education

Bachelor's degree in Engineering or related field

Tools

CAD software

Validation protocols (IQ/OQ/PQ)

Job description

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

As a Plant Engineer II, you will play a key role in optimizing and maintaining manufacturing equipment to ensure efficient and compliant pharmaceutical fill-finish production. This position requires a skilled engineer with understanding of equipment design, troubleshooting, and process improvement. The Plant Engineer II will work closely with cross-functional teams to support continuous improvement initiatives and contribute to the success of site projects while working closely with experienced senior engineers.

Essential Duties and Responsibilities

• Lead the design and specification of manufacturing equipment, ensuring compliance with project requirements.
• Coordinate the installation, commissioning, and validation of new equipment.
• Troubleshoot and resolve equipment-related issues, working closely with cross-functional teams.
• Develop and implement preventive maintenance programs for critical equipment.
• Contribute to the continuous improvement of manufacturing processes through equipment upgrades and modifications.
• Mentor and guide entry-level engineers in equipment-related tasks.

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.

Qualifications

EXPERIENCE

• 4+ years' experience with GMP, ISO, and/or an FDA-regulated environment is required.
• Proficiency in engineering principles and their application to pharmaceutical manufacturing processes

EDUCATION

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

QUALITIES

• Strong project management skills
• Knowledge of regulatory requirements and industry quality standards
• Support initiatives to completion
• Excellent communication and interpersonal skills with the ability to work collaboratively across departments
• 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.

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, Equity and Inclusion 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.