Sr. Spclst, Engineering

Job Description

Our Engineers support internal and external manufacturing operations and continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. 

Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our company, we’re inventing for life. 

Search Firm Representatives Please Read Carefully: Our company is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at our company via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event the candidate is hired by us as a result of the referral or through other means.

Position Responsibilities:

• The Senior Specialist operates under the guidance of the Technology Director or an Associate Director supporting a Line of Business (e.g. Large Molecule, Small Molecule or Animal Health).

• The individual collaborates with other Integrated Project Team (IPT) members (e.g., Project Management, Technology, Maintenance, Automation, Plant Operations and Safety), Engineering Firms and Vendors to progress deliverables.

• The Senior Specialist would be responsible for planning, design, and implementation of capital projects including scope generation, process & facility design, equipment selection, vendor interaction, factory acceptance testing, construction support, equipment qualification, facility start-up, process technology transfer, and demonstrations as part of an end-to-end capital management program. 

• The Senior Specialist shall exhibit strong leadership, interpersonal, collaboration and communication skills for both decision making and guiding team members.

• The candidate should have a strong understanding of the line of business, understand lean design and delivery, implement standard work and be able to lead technical areas and small capital projects from an end-to-end perspective.

• Flexibility with travel up to 50% and work location is also required.

Education Minimum Requirement: 

• B.S. in Engineering

Required Experience and Skills: 

• This position will function as a Process Engineer with prior experience supporting capital projects for Biologics, Vaccines or other GMP products.

• Minimum 5 years of experience with engineering design, equipment operation, vendor interface, risk assessment, process safety and industry guidance is essential for delivery of assets and project realization.

• Depending on Project Size, responsibilities will range from leading a small to medium project to supporting a portion of a large project.

• Experience with an equipment life cycle approach including specification, selection, testing & commissioning, troubleshooting and qualification

• Excellent collaboration and engagement as a team player with strong interpersonal and communication skills

• Analytical and Problem Solving Skills

• Project/Time Management skills which deliver on time and quality work .

• Ability to travel, both domestic and international. 

Preferred Experience and Skills:

• Leadership of a small capital project or a portion of a large capital project, including interface with IPT members in support of capital project delivery

• Ability to assess multiple options and select a leading approach

• Core knowledge should include specification of unit operations, P&ID development, Hazard Analysis, equipment operation, commissioning & qualification.

• Management of OEM filling and lyophilization equipment packages and their integration into a drug product facility

• Familiar with chemical handling, bio-safety, industrial hygiene, containment approaches in terms of solution development

• Operating within cost and schedule constraints of project and department; understanding of capital management practices including project controls and stage gates approvals

• Peer review across multiple projects

• Maintaining knowledge of best practices & industry trends; may participate in professional/tec