Senior Project Manager, Engineering
Posted on: April 8, 2021
Andelyn Biosciences is an industry leading cGMP
productionfacility dedicated to advancing the field of gene
therapy. Our mission is touse our knowledge, resources, technology,
and experience in the field oftranslational and regulatory science,
to develop new, safe, and effectivelong-term treatments for
diseases. There is no disease too rare and nochallenge too
difficult as we strive to make a difference with every productand
to leave hope on the minds of every patient and their families.
Andelyn is primarilya full-service manufacturer of Adeno Associated
Virus (AAV). We work withover 100 clients each year to manufacture
AAV at development, toxicology,clinical and commercial quality.
The--Senior Project Manager, Engineering--isaccountable for
facility design/build, construction project management and
theharmonization of facility engineering systems and maintenance
and Health,Safety and Environmental procedures and practice to
assure proper officeaccommodation, cleanroom manufacturing space,
warehousing and a safe workenvironment in compliance with all
state, federal, and regulatory governingagencies. Principal Duties
- Harmonized facility maintenance procedures and practices
tocover critical systems such as HVAC, sanitization, security,
safety program,metrology, preventative/predictive maintenance
program, contract services,environmental permitting, critical
facility documentation, space planning,facility asset management
(excluding IT related assets), building and maintenancemonitoring
systems in compliance with local and federal regulatory
authoritiessuch as: OSHA, state permits, FDA, EMA, etc.
- Continuous improvement program to review opportunities toassure
that facility maintenance, safety and environmental related systems
andprocedures across all sites run in an efficient, cost effective
- Construction project management for a biologic manufacturingand
filling facility design/construction/qualification performed on
time and onbudget.
- Engineering consultation on new facility projects at
- Manages all project administration efforts, to
includecontract(s), budget management and consultant procurement
- Responsible for space planning and allocation to
optimizebuilding space and layout for current and future needs;
coordinate officemoves, including distribution of furniture and
- Monitor and coordinate the work of outside contractorsincluding
general contractors, architects, engineers, and material
- Define, plan, and manage the full scope of
- Forecast, track, and manage project budgets, POs, andinvoices
in accordance with generally accepted accounting principles
- Coordinate appropriate internal and external
resources(technical & non-technical) to meet project needs
- Coordinate project commissioning, qualification, andvalidation
- Review drawings and specification for accuracy andconsistency
with existing standards
- Environmental permitting at all sites up to date and currentas
required by state and federal authorities
- Safety program that meets OSHA and state requirements toassure
a safe work environment for all employees.
- GMP compliant metrology process for all equipment
- As built drawings and process flow diagrams - maintained inan
up to date status and readily retrievable
- Performance metrics for Facility and HSE systems/programs
- Emergency response plan
- A safe work environment for department employees.
- Annual proposed expense and capital budget for
- Department staff compliance with corporate and site-specificHR,
safety and business policies and practice.
- Job specific curriculum for the training and
professionaldevelopment of department staff. Knowledge, skills, and
- Bachelor's Degree and/or equivalent combination of
relevanteducation and experience will be considered.
- 10 years of related experience and/or training inEngineering or
related field required
- Experience in new construction andqualification/commissioning
of a new facility or expansion
- Strong project management and organizational skills.
- Extensive cleanroom, packaging/filling & Isolatorqualification,
and operation experience.
- Experience working in an FDA/EU/RoW regulated
manufacturingfacility preferably in sterile injectables
- Expert computer applications skills (Excel, Word, Visio,
- Excellent team facilitation, communication and
- Excellent documented leadership skills and navigate in afast
- Demonstrated ability to assign priorities in a fast-pacedand
changing environment Minimum Physical Requirements
- Sitting for extended periods Constantly (67-100%)
- Talking on the phone/in person Constantly (67-100%)
- Typing on a computer keyboard Constantly (67-100%)
Keywords: Aircall, Bloomington , Senior Project Manager, Engineering, Executive , Columbus, Indiana
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