Previous Pharmaceutical/Biotech experience is mandatory for this role.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems, and facilities. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.
This role is for C&Q Manager will require to work on the validation of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.
The work will require working out of client's facilities, which are in Boulder, Colorado.
Responsibilities
- Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities used in life science manufacturing, such as bioreactors, tanks, CIP, Buffers, Media, Chrom, TFF, washers & autoclaves, etc.
- Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
- Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all specifications are met.
- Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
- Experience with C&Q of upstream or downstream bioprocess systems is required. Experience with C&Q of other process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset.
- Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
- Engage other departments, as required, for design reviews and decisions.
- Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
- Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
- Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
- Visit construction and installation sites following all site safety requirements.
- Other duties as assigned by client, and/or MMR, based on workload and project requirements.
Qualifications
- Excellent written and spoken English is required including the preparation of technical documents in English
- Years of experience: 8+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
- Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
- Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
- Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is required
- Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset, but not required.
- Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
- Experience with preparation and execution of URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
- Ability to lift 50 lbs.
- Science degree, or equivalent studies such as Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline along with industry experience.
- Ability to handle multiple projects and work in a fast-paced environment.
- Strong multi-tasking skills
Compensation: 90,000$ - 145,000$ based on experience.
