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: 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.
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.
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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, 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.
Skills Required
- 4+ years experience with GMP, ISO, and/or FDA-regulated environment
- Bachelor's degree in Engineering, Science, or related field
- Proficiency in engineering principles applied to pharmaceutical manufacturing processes
- Experience designing, specifying, installing, commissioning, and validating manufacturing equipment
- Experience developing and executing equipment qualification protocols and validation procedures (IQ/OQ/PQ)
- Experience developing and implementing preventive maintenance programs for critical equipment
- Strong project management skills
- Knowledge of regulatory requirements and industry quality standards
- Excellent communication and interpersonal skills; ability to work cross-functionally
- Ability to mentor and guide entry-level engineers
- Commitment to EH&S policies and safe work practices (including Hot Work and Lock Out Tag Out)
PCI Pharma Services Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about PCI Pharma Services and has not been reviewed or approved by PCI Pharma Services.
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Retirement Support — Feedback suggests the company provides a 401(k) with an employer match in the mid‑single‑digit range, with immediate vesting noted in certain cases. This is viewed as a solid component of the overall package.
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Leave & Time Off Breadth — PTO and paid holidays are commonly available, and some roles indicate vacation is accessible from early tenure. Availability of time off is frequently described as a positive element of the package.
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Affordable Benefits — Health insurance is sometimes described as reasonably priced depending on plan tier. Feedback suggests core medical, dental, and vision coverage is part of a standard offering.
PCI Pharma Services Insights
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
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