Associate Director, Engineering - Capital Projects

Job Description

The Associate Director operates under the guidance of a Director in the Global Engineering Solutions team supporting Technology Center, Large Molecule Process Engineering.   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 Associate Director would be responsible for, but not limited to: 

• Planning, design, and implementation of capital projects including scope generation

• Process & facility design

• Capacity Assessments

• Equipment selection

• Vendor management and interaction

• Factory acceptance testing

• Facility start-up and Commissioning

• Construction support and/or management

• Equipment qualification

• Technology transfer

• Process demonstration

Candidates possessing capital management experience or expertise are preferred for this role.  Ideal candidate will possess superior communication and technical skills, a team player with the ability to work independently.  We are seeking candidates with outstanding records of achievement and demonstrated leadership abilities, candidates who are analytical and inquisitive about the interrelationships of various components, and perceptive, quick learners committed to making a difference in the pursuit of manufacturing high-quality, market-leading pharmaceutical, biologic and vaccine products.

The candidate should have a strong understanding of the line of business, understand capital project and technical team management, implement standard work and be able to lead technical areas and small capital projects from an end to end perspective.  Position is project-based, requiring on-site support 5 days per week, for up to 3 years. Flexibility with travel up to 50% and work location is also required based on project need.

Education Requirements:

• Bachelors Degree or higher in Mechanical, Chemical, BioChem, BioMech, or Computer/Electric Engineering or Applicable Science

 Required Experience and Skills: 

• Minimum of seven years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (consideration given to advanced degrees)

• Minimum of two years project leadership and/or management

• Written and verbal communication, leadership and teamwork skills. 

• Experience with engineering design, equipment start-up and operation, vendor interface, risk assessment and process safety

• Ability to travel, both domestic and international

Preferred Experience and Skills:

• Downstream, or Bioconjugation Drug Substance, and/or Drug Product Process Engineering Experience

• Estimating and/or Project Controls experience or expertise

• Capital Management Process Experience

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

• Construction Management Experience

• Experience with Potent Compound manufacturing, Process Safety, and Industrial Hygiene.

Required Skills:

Capital Project Management, Change Management, Clinical Manufacturing, Decision Making, Drug Product Manufacturing, Engineering Design, GMP Compliance, Industrial Hygiene, Interpersonal Relationships, Lean Manufacturing, Manufacturing Scale-Up, Oral Communications, Project Leadership, Project Management, Regulatory Compliance, Risk Assessments, Root Cause Analysis (RCA), Strategic Thinking, Team Player, Technical Transfer

Preferred Skills:

Antibody Drug Conjugates (ADC)

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US and Puerto Rico Residents Only:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis o