Overview / Responsibilities Wood PLC, on a global scale, serves the Pharma-Bio, Oil & Gas, Federal, Infrastructure, Manufacturing, Mining, and Power Industries. Our Philadelphia office has become the center of excellence for our global Life Sciences network. It provides process engineering, process design, and commissioning - qualification - validation (CQV) services to pharmaceutical/biotechnology clients worldwide. For projects of every scale, we provide services that support a facility's entire life cycle to bring life-saving therapeutics from concept through fruition. Learning from our team of industry-leading experts in facility design, regulatory standards, and project management will pay dividends toward your future engineering career.
Our CQV group at Wood is growing and we are adding to our well respected and established team of
Deviations Investigator - Senior Specialists. We are looking for candidates experienced in manufacturing, process, engineering, commissioning, qualification and/or validation within the pharmaceuticals, biopharmaceuticals, vaccines, and aseptic processing areas. If you are interested in working with a global leader in life sciences and possess the skill and drive to flourish in a dynamic and exciting environment, apply today!
This position is 100% remote with no travel to the client. Must be physically located within the United States. Must have reliable a high-speed internet connection. Must have excellent communication (both written and verbal), organization, and planning skills in addition to BioPharma facilities and unit operations with an emphasis on the resolution of deviations related to equipment and calibration. Key Responsibilities - Preparation and authoring of all deviation investigation deliverables.
- Ability to carry out, complete and document Root Cause analysis.
- Ability to work independently, under the direction of the client and with client-side stakeholders.
- Ability to read, understand and GMP review all BioPharma documentation including P&IDs , TOPs, Maintenance records, etc.
- Manage punch lists and effectively execute deviation resolutions.
- Author, consult with stakeholders, and issue effective CAPAs.
- Effectively interfacing and communicating with 3 rd parties, client and Wood team.
- Ability to multi-task and adjust priorities to meet aggressive investigation timelines.
- Able to complete work 100% remote is essential.
#LI-Remote Skills / Qualifications Skills/Qualifications - Degree in engineering (preferably) or life sciences or suitable industry experience.
- Minimum of 5+ years of direct experience in CQV and/or Engineering.
- Experience in the documentation, investigation, and resolution of deviations & CAPAs
- Strong and clear communication skills, both written and verbal.
- Ability to effectively interface with Wood management, co-workers, clients, vendors and subcontractors.
- Understanding with advanced knowledge of common unit operations and processes used in biopharma/pharmaceutical manufacturing.
- Thorough knowledge of cGMPs as related to the pharmaceutical industry.
- Strong computer skills.
- Customer service oriented.
- Ability to understand the challenges of managing a schedule of multiple investigations and with the drive to close them out successfully.
- Ability to work safely and keep the safety of others in mind.
- Ability to recognize hazards and communicate these to the appropriate individuals.
Physical Requirements - While performing the duties of this job the employee is frequently required to: type, sit, and stand and requires computer display close vision work.
Company Overview Wood is a global leader in engineering and consultancy across energy and the built environment, helping to unlock solutions to some of the world's most critical challenges. We provide consulting, projects and operations solutions in more than 60 countries, employing around 40,000 people. www.woodplc.com
Diversity Statement We are an equal opportunity employer that recognises the value of a diverse workforce. All suitably qualified applicants will receive consideration for employment on the basis of objective criteria and without regard to the following (which is a non-exhaustive list): race, colour, age, religion, gender, national origin, disability, sexual orientation, gender identity, protected veteran status, or other characteristics in accordance with the relevant governing laws.
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