The Role
Deliver capital engineering projects across design, procurement, installation, commissioning, qualification, and validation. Manage project scope, schedules, budgets, risks, technical documentation, and stakeholder coordination while ensuring GMP and regulatory compliance. Execute FAT, SAT, IQ, OQ, and PQ activities; prepare controlled documents and technical specifications; support audits, inspections, and regulatory interactions. The role also requires stakeholder management, communication, problem-solving, and experience with packing lines and risk-based CQV approaches.
Summary Generated by Built In
POSITION SUMMARY:
The Project Engineer is responsible for delivering capital engineering projects across the full project lifecycle, from design and scoping through procurement, installation, commissioning, and qualification. The role ensures projects are delivered safely, on time, within budget, and in compliance with applicable GMP and regulatory standards.
The Project Engineer is responsible for delivering capital engineering projects across the full project lifecycle, from design and scoping through procurement, installation, commissioning, and qualification. The role ensures projects are delivered safely, on time, within budget, and in compliance with applicable GMP and regulatory standards.
DUTIES AND RESPONSIBILITIES:
- Support and deliver capital engineering projects from concept through completion.
- Support delivery of project scope, schedules, and budgets to ensure successful outcomes
- Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
- Assists in authors, revises, reviews, and completes controlled documents for CQV projects.
- Assists to review and qualify equipment for commissioning, qualification, and validation activities.
- Supports to write and review GMP and GDP documents and technical specifications.
- Collaborate with multiple departments on assigned project activities and deliverables.
- Assist to initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ,
- Assist with project scope, budget, schedule, and risk management.
- Coordinate engineering design, construction, commissioning, and validation activities.
- Prepare technical specifications, project documentation, and procurement requirements.
- Ensure projects are delivered safely, compliantly, on time, and within budget.
- Support audits, inspections, and regulatory interactions as required
- Maintain clear, professional communication with all project stakeholders
DEMONSTRATED COMPETENCIES:
- Business Development - Identify and target potential clients. Work in a team environment; develop and execute a plan, in alignment with company vision, mission and strategic plans to engage potential customers.
- Relationship Building – Works with and across formal and informal professional and social networks to build long-term partnerships and connections in the life science industry and Internal team.
- Negotiation Skills – Active listening, needs assessment, and presents visions to build a consensus.
- Analytical Skills – Identifies, researches, and demonstrates logical reasoning to communicate critical information.
- Rational Persuasion – Presents key factors, influencing factors, and strategic goals to assist stakeholders in identifying solutions.
- Interpersonal Awareness – Ability to be aware of how actions, ideas, and communication can/does affect people and their outcomes.
- Agility – Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines.
Requirements
REQUIREMENTS:
- Bachelor Degree in Engineering or Science.
- Minimum 3 years’ experience in commission, qualify and validating facilities or capital projects within a GMP/GxP-regulated environment.
- Knowledge of project management principles, commissioning, qualification, and engineering systems.
- Experience with risk-based CQV approaches.
- Experience with packing line.
- Hands-on experience executing and facilitating FAT, SAT, IQ, OQ, and PQ activities.
- Understanding of quality systems, risk management, and contract administration.
- Strong stakeholder management, communication, and problem-solving skills.
Skills Required
- Bachelor's degree in Engineering or Science
- Minimum 3 years of experience commissioning, qualifying, and validating facilities or capital projects in a GMP/GxP-regulated environment
- Knowledge of project management principles, commissioning, qualification, and engineering systems
- Experience with risk-based CQV approaches
- Experience with packing lines
- Hands-on experience executing and facilitating FAT, SAT, IQ, OQ, and PQ activities
- Understanding of quality systems, risk management, and contract administration
- Strong stakeholder management, communication, and problem-solving skills
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
