Project Engineer

About the role

Almac Group is currently seeking a Project Engineer for our Souderton, PA location. The Project Engineer will be responsible for the engineering design, project management, procurement, commissioning and optimization of process and utility equipment to the highest industrial and pharmaceutical standards. The focus of the work will be to ensure that processes operate efficiently and safely, and in compliance with cGxP. Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing over 7,500 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life. Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.

Responsibilities

• Engage and liaise with stakeholders.
• Lead / Support development of key project documentation (URS, FDS, SDS, HDS, Data sheets).
• Ensure design development and vendor proposals comply with user requirements, engineering standards and best practise.
• Lead / Support development of technical design.
• Generate and update engineering drawings including P&IDs.
• Lead / Support the development of engineering strategies.
• Engage with vendors through technical documents (RFI/RFP/RFQ) and technical meetings to ensure work packages are coordinated and integrated.
• Coordinate delivery of work packages on major projects.
• Lead / Support pre-qualification assessment of vendors and contractors.
• Support project procurement and cost management.
• Report work package compliance (scope/cost/time/quality) to project manager and maintain the project risk register.
• Day-to-day coordination with contractors and resolution of technical queries.
• Lead / Support all commissioning activities on plant and equipment and ensure close out of deficiencies.
• Ensure CDM compliance of work packages.
• Participate in Design Risk Assessments.
• Participate in project risk reviews.
• Coordination of contractors, assess RAMS and issue Permit to Work.
• Participate in Process Safety reviews/studies.
• Conduct Site Safety inspections.
• Support in delivery of technical investigation within defined time frame.
• QMS GXP documentation compilation support (SOPs, CCs, CAPAs, QIs, etc).

Qualifications

• BS Degree (or equivalent) with engineering experience.
• 5+ years of previous experience within a project engineering function.
• Proficiency in the use of Microsoft Office packages.
• Understanding of commissioning processes and associated documentation.
• Preferred: OSHA10 (Occupational Safety and Health Administration) certification or equivalent safety qualification.
• Preferred: Knowledge of working within a pharmaceutical facility.
• Preferred: Knowledge and Experience of working within the OSHA regulations on a construction site.
• Preferred: Knowledge of AutoCAD, HAZOP assessments & document management systems.

Benefits

• Medical, Vision & Dental benefits from the 1st of the month following start date.
• 20 days PTO per year, accrued monthly following start date.
• 12 holidays per year as well as one day for Annual Diversity Day.
• Company paid Long and Short-term disability along with Life Insurance.
• 401k company contribution.
• Professional development programs/ continuous learning opportunities.

Schedule

M-F 8am-5pm