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PSC Biotech Corporation · 2 days ago
Project Engineer/Manager
Frederick, MD
Full-time
Onsite
Senior Level
7+ years exp
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Responsibilities
Identify and contribute to the development of long-term strategies for global operations and CapEx projects including capacity planning, expansion, and resource/project management. (Project activities include but are not limited to expansions, upgrades, commissioning, qualification, validation, engineering, for a range of pharmaceutical facilities, utilities, equipment, systems, etc.)
Lead the generation and alignment of integrated project plans across all functional teams.
Analyze project requirements, risks, value, costs, etc., to develop tailored solutions to complex project objectives.
Provide and maintain consistent and effective communication with all project stakeholders.
Develop comprehensive project plans, scopes of work, and schedules, ensuring alignment with budgets, client objectives, resource allocation, and regulatory requirements.
Identify potential risks in project plans and develop mitigation strategies to ensure minimum disruption with project timelines and deliverables.
Lead change initiatives and manage the impact on global operations.
Drive ongoing improvements in global operations.
Provide financial reports and forecasts to support on-going strategic decision-making.
Provide hands-on engineering support on the manufacturing floor as needed. This includes supporting the execution of engineering projects, including commissioning, qualification, validation, quality, and maintenance.
Troubleshoot and resolve operational issues to minimize downtime and ensure smooth production.
Ensure compliance with regulatory requirements and industry standards throughout project lifecycles, overseeing the quality processes and supporting audit readiness for client needs.
Collaborate closely with internal teams, senior management, and external stakeholders, and effectively coordinate action plans and deliverables among teams in various geographic locations.
This role requires travel.
Qualification
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Required
Bachelor’s degree or higher in related engineering discipline.
7-10+ years of proven project management experience within the pharmaceutical manufacturing/bioscience industries. PMP certification is a plus.
Hands-on engineering experience in the pharmaceutical manufacturing environment, with the ability to provide direct engineering support and technical expertise.
Experienced leading and executing large capital projects and supporting overall global operations, including budgeting, scheduling, and resource allocation. Large capital projects within construction, validation, engineering, biologics, small molecules, cell and gene therapy, and overall bio-science space.
Experience in global operations management, dealing with multiple sites and cross-functional teams.
Advanced knowledge of cGMP, FDA, regulatory requirements, and industry regulations.
Strong understanding of engineering principles, manufacturing processes, and equipment used in pharmaceutical production.
Proven ability to manage multiple projects and priorities in a fast-paced environment.
Ability to identify and implement process improvements to increase efficiency and reduce costs.
Excellent interpersonal skills for effective communication with stakeholders at all levels.
Ability to analyze complex problems, develop solutions, and make data-driven decisions.
Ability to adapt to changing priorities and deadlines.
50-75% travel is required.
Preferred
PMP certification.
Benefits
Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
Financial Perks and Discounts
Company
PSC Biotech Corporation
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support.
201-500 employees
H1B Sponsorship
PSC Biotech Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (2)
2022 (4)
2021 (7)
2020 (2)
Funding
Current Stage
Growth StageLeadership Team
John Clapham
Founder, President & CEO
Company data provided by crunchbase
